Abaloparatide

Last updated

Abaloparatide
Clinical data
Trade names Tymlos
Other namesBA058, BIM-44058
AHFS/Drugs.com Monograph
MedlinePlus a617038
License data
Routes of
administration 		Subcutaneous injection
ATC code
Legal status
Legal status
Identifiers
  • L-alanyl-L-valyl-L-seryl-L-α-glutamyl-L-histidyl-L-glutaminyl-L-leucyl-L-leucyl-L-histidyl-L-α-aspartyl-L-lysylglycyl-L-lysyl-L-seryl-L-isoleucyl-L-glutaminyl-L-α-aspartyl-L-leucyl-L-arginyl-L-arginyl-L-arginyl-L-α-glutamyl-L-leucyl-L-leucyl-L-α-glutamyl-L-lysyl-L-leucyl-L-leucyl-2-methylalanyl-L-lysyl-L-leucyl-L-histidyl-L-threonyl-L-alaninamide
CAS Number
PubChem CID
DrugBank
ChemSpider
UNII
KEGG
ChEMBL
Chemical and physical data
Formula C174H299N56O49
Molar mass 3959.649 g·mol−1
3D model (JSmol)
  • CC[C@H](C)[C@@H](C(=O)N[C@@H](CCC(=O)N)C(=O)N[C@@H](CC(=O)O)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCNC(=N)N)C(=O)N[C@@H](CCCNC(=N)N)C(=O)N[C@@H](CCCNC(=N)N)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CC(C)C)C(=O)NC(C)(C)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](Cc1cnc[nH]1)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](C)C(=O)N)NC(=O)[C@H](CO)NC(=O)[C@H](CCCCN)NC(=O)CNC(=O)[C@H](CCCCN)NC(=O)[C@H](CC(=O)O)NC(=O)[C@H](Cc2cnc[nH]2)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CCC(=O)N)NC(=O)[C@H](Cc3cnc[nH]3)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CO)NC(=O)[C@H](C(C)C)NC(=O)[C@H](C)N
  • InChI=1S/C174H300N56O49/c1-26-93(20)136(228-165(274)126(80-232)224-141(250)101(39-28-32-56-176)200-129(236)78-195-140(249)100(38-27-31-55-175)201-161(270)123(73-133(243)244)223-160(269)121(71-98-76-190-82-197-98)220-158(267)118(68-90(14)15)216-155(264)114(64-86(6)7)213-148(257)107(45-50-127(180)234)207-159(268)120(70-97-75-189-81-196-97)219-151(260)111(49-54-132(241)242)209-164(273)125(79-231)225-167(276)135(92(18)19)227-139(248)94(21)179)168(277)210-108(46-51-128(181)235)149(258)222-124(74-134(245)246)162(271)217-112(62-84(2)3)152(261)205-105(44-37-61-194-173(187)188)143(252)203-103(42-35-59-192-171(183)184)142(251)204-104(43-36-60-193-172(185)186)144(253)206-110(48-53-131(239)240)150(259)214-115(65-87(8)9)154(263)215-113(63-85(4)5)153(262)208-109(47-52-130(237)238)147(256)202-102(40-29-33-57-177)145(254)211-116(66-88(10)11)156(265)218-119(69-91(16)17)166(275)230-174(24,25)170(279)226-106(41-30-34-58-178)146(255)212-117(67-89(12)13)157(266)221-122(72-99-77-191-83-198-99)163(272)229-137(96(23)233)169(278)199-95(22)138(182)247/h75-77,81-96,100-126,135-137,231-233H,26-74,78-80,175-179H2,1-25H3,(H2,180,234)(H2,181,235)(H2,182,247)(H,189,196)(H,190,197)(H,191,198)(H,195,249)(H,199,278)(H,200,236)(H,201,270)(H,202,256)(H,203,252)(H,204,251)(H,205,261)(H,206,253)(H,207,268)(H,208,262)(H,209,273)(H,210,277)(H,211,254)(H,212,255)(H,213,257)(H,214,259)(H,215,263)(H,216,264)(H,217,271)(H,218,265)(H,219,260)(H,220,267)(H,221,266)(H,222,258)(H,223,269)(H,224,250)(H,225,276)(H,226,279)(H,227,248)(H,228,274)(H,229,272)(H,230,275)(H,237,238)(H,239,240)(H,241,242)(H,243,244)(H,245,246)(H4,183,184,192)(H4,185,186,193)(H4,187,188,194)/t93-,94-,95-,96+,100-,101-,102-,103-,104-,105-,106-,107-,108-,109-,110-,111-,112-,113-,114-,115-,116-,117-,118-,119-,120-,121-,122-,123-,124-,125-,126-,135-,136-,137-/m0/s1
  • Key:BVISQZFBLRSESR-XSCWXTNMSA-N

Abaloparatide, sold under the brand name Tymlos among others, is a parathyroid hormone-related protein (PTHrP) analog medication used to treat osteoporosis. [1] It is an anabolic (i.e., bone growing) agent. [3]

Contents

The most common side effects include hypercalciuria (high calcium levels in the urine) and dizziness. [2] Other common side effects include back pain, nausea, headache, joint pain, high blood pressure, reactions at the injection site, and palpitations (a forceful heartbeat that may be rapid or irregular). [2]

Abaloparatide was approved for medical use in the United States in April 2017, [1] [4] [5] [6] [7] and in the European Union in December 2022. [2]

Medical uses

Abaloparatide is indicated to treat postmenopausal women with osteoporosis at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy. [1] [2] [5]

In the US it is also indicated for the treatment to increase bone density in men with osteoporosis at high risk of fracture or in people who have failed or are intolerant to other available osteoporosis therapy. [1] [8]

Side effects

The most common side effects reported by more than 2% of clinical trials subjects are hypercalciuria, dizziness, nausea, headache, palpitations, fatigue, upper abdominal pain and vertigo. [1]

Preclinical studies revealed that abaloparatide systemic daily administration leads to a dose- and time-dependent increase in the incidence of osteosarcoma in rodents. [9] It is unknown if abaloparatide will cause osteosarcoma in humans. [1] <

Pharmacology

Abaloparatide is 34 amino acid synthetic analog of PTHrP. It has 41% homology to parathyroid hormone (PTH) (1-34) and 76% homology to parathyroid hormone-related protein (PTHrP) (1-34). [10] It works as an anabolic agent for the bone, through selective activation of the parathyroid hormone 1 receptor (PTH1R), a G protein-coupled receptor (GPCR) expressed in the osteoblasts and osteocytes. Abaloparatide preferentially binds the RG conformational state of the PTH1R, which in turn elicits a transient downstream cyclic AMP signaling response towards to a more anabolic signaling pathway. [11] [12]

History

Preclinical studies

Abaloropatide was invented at Ipsen. [13] It was known as BIM-44058 during pre-clinical studies and as BA058 while under clinical development. The anabolic effects of abaloparatide on bone were demonstrated in two preclinical studies conducted in ovariectomized rats. Both studies showed increased cortical and trabecular bone volume and density, and trabecular microarchitecture improvement in vertebral and nonvertebral bones after short-term [14] and long-term [15] daily subcutaneous injection of abaloparatide compared to controls. Recent studies indicated a dose-dependent increased in bone mass and strength in long-term abalorapatide treatment. [16]

Clinical Trials

Phase II trials were initiated in 2008. A 24-week randomized trial was conducted in postmenopausal women with osteoporosis (n=222) assessing bone mass density (BMD) changes as the primary endpoint. [17] Significant BMD increase at doses of 40 and 80 mcg were found in the lumbar spine, femur and hips of abaloparatide-treated participants compared to placebo. Additionally, abaloparatide showed superior anabolic effects on the hips compared to teriparatide. [18]

In the phase III (2011-2014) Abaloparatide Comparator Trial in Vertebral Endpoints (ACTIVE) trial, an 18-months randomized, multicenter, double-blinded, placebo-controlled study evaluated the long-term efficacy of abaloparatide compared to placebo and teriparatide in 2,463 postmenopausal women (mean age 69 years). [19] Women who received daily injections of abaloparatide experienced substantial reduction in the incidence of fractures compared to placebo. Additionally, greater BMD increase at 6, 12 and 18 months in spinal, hips and femoral bones was observed in abaloparatide compared to placebo and teriparatide-treated subjects. [20]

Participants who completed 18 months of abaloparatide or placebo in the ACTIVE study were invited to participate in an extended open-labeled study - ACTIVExtend study (2012-2016). [21] Subjects (n=1139) received additional 2 years of 70 mg of alendronate, Vitamin D (400 to 800 IU), and calcium (500–1000 mg) supplementation daily. Combined abaloparatide and alendronate therapy reduced significantly the incidence of vertebral and nonvertebral fractures. [22]

A clinical trial assessing the effectiveness of abaloparatide in altering spinal bone mineral density (BMD) in male subjects is expected to start in the first quarter of 2018. If successful, Radius Health aims to submit a sNDA to expand the use of abaloparatide-SC to treat men with osteoporosis. [23]

In addition to the injectable form of abaloparatide, a transdermal patch is also in development. [3]

Society and culture

Radius Health filed a Marketing Authorization Application (MAA) in November 2015, [24] which was validated in December 2015, and still under regulatory assessment by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). As in July 2017, the CHMP issued a second Day-180 List of Outstanding Issues, which Radius is addressing with the CHMP. [23]

In February 2016 a NDA was filed to the FDA, Radius NDA for abaloparatide-SC was accepted in May 2016. [25] A Prescription Drug User Fee Act (PDUFA) date was initially granted on 30 March 2016, but then extended to 30 June 2017. [26]

On 13 October 2022, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Eladynos, intended for the treatment of osteoporosis in postmenopausal women at increased risk of fracture. [27] The applicant for this medicinal product is Radius Health Ireland Ltd. [27] Abaloparatide was approved for medical use in the European Union in December 2022. [2] [28]

Intellectual Property

Radius Health holds three patents on abaloparatide-SC, with expiration dates from 2027 to 2028. [29] The patents relate to the drug composition (US 8148333), and the drug delivery methods (US 7803770 B2 and US 8748382-B2).

Sheffield University

Tatiane Vilaca a postdoctoral research associate at the School of Medicine and Population Health and Richard Eastell professor of bone metabolism, both at the University of Sheffield wrote a Creative Commons article for The Conversation [30]

Economics

Abaloparatide-SC is manufactured by Radius Health, Inc, a biomedical company based in Boston, Massachusetts. [23] The firm reported that sales for abaloparatide were $3.5 million for the third quarter of 2017. [23]

In July 2017, Radius Health licensed rights to Teijin Limited for abaloparatide-SC manufacture and commercialization in Japan. Teijin is developing abaloparatide-SC under agreement with Ipsen Pharma S.A.S., and is conducting a phase III clinical trial in Japanese patients with osteoporosis. [31]

Related Research Articles

<span class="mw-page-title-main">Osteoporosis</span> Skeletal disorder

Osteoporosis is a systemic skeletal disorder characterized by low bone mass, micro-architectural deterioration of bone tissue leading to more porous bone, and consequent increase in fracture risk.

<span class="mw-page-title-main">Parathyroid hormone</span> Mammalian protein found in humans

Parathyroid hormone (PTH), also called parathormone or parathyrin, is a peptide hormone secreted by the parathyroid glands that regulates the serum calcium concentration through its effects on bone, kidney, and intestine.

<span class="mw-page-title-main">Teriparatide</span> Pharmaceutical drug for treating osteoporosis

Teriparatide, sold under the brand name Forteo, is a form of parathyroid hormone (PTH) consisting of the first (N-terminus) 34 amino acids, which is the bioactive portion of the hormone. It is an effective anabolic agent used in the treatment of some forms of osteoporosis. Teriparatide is a recombinant human parathyroid hormone analog. It has an identical sequence to the 34 N-terminal amino acids of the 84-amino acid human parathyroid hormone.

<span class="mw-page-title-main">Raloxifene</span> Chemical compound

Raloxifene, sold under the brand name Evista among others, is a medication used to prevent and treat osteoporosis in postmenopausal women and those on glucocorticoids. For osteoporosis it is less preferred than bisphosphonates. It is also used to reduce the risk of breast cancer in those at high risk. It is taken by mouth.

<span class="mw-page-title-main">Zoledronic acid</span> Chemical compound

Zoledronic acid, also known as zoledronate and sold under the brand name Zometa among others, by Novartis among others, is a medication used to treat a number of bone diseases. These include osteoporosis, high blood calcium due to cancer, bone breakdown due to cancer, Paget's disease of bone and Duchenne muscular dystrophy (DMD). It is given by injection into a vein.

<span class="mw-page-title-main">Osteopenia</span> Abnormally low bone mineral density

Osteopenia, known as "low bone mass" or "low bone density", is a condition in which bone mineral density is low. Because their bones are weaker, people with osteopenia may have a higher risk of fractures, and some people may go on to develop osteoporosis. In 2010, 43 million older adults in the US had osteopenia. Unlike osteoporosis, osteopenia does not usually cause symptoms, and losing bone density in itself does not cause pain.

<span class="mw-page-title-main">Nandrolone decanoate</span> Anabolic steroid

Nandrolone decanoate, sold under the brand names Rolon and Deca-Durabolin, among others, is an androgen and anabolic steroid (AAS) medication which is used primarily in the treatment of anemias and wasting syndromes, as well as osteoporosis in menopausal women. It is given by injection into muscle or fat once every one to four weeks.

<span class="mw-page-title-main">Sclerostin</span> Protein-coding gene in the species Homo sapiens

Sclerostin is a protein that in humans is encoded by the SOST gene. It is a secreted glycoprotein with a C-terminal cysteine knot-like (CTCK) domain and sequence similarity to the DAN family of bone morphogenetic protein (BMP) antagonists. Sclerostin is produced primarily by the osteocyte but is also expressed in other tissues, and has anti-anabolic effects on bone formation.

<span class="mw-page-title-main">Ibandronic acid</span> Chemical compound

Ibandronic acid is a bisphosphonate medication used in the prevention and treatment of osteoporosis and metastasis-associated skeletal fractures in people with cancer. It may also be used to treat hypercalcemia. It is typically formulated as its sodium salt ibandronate sodium.

<span class="mw-page-title-main">Denosumab</span> Human monoclonal antibody

Denosumab, sold under the brand names Prolia and Xgeva among others, is a human monoclonal antibody used for the treatment of osteoporosis, treatment-induced bone loss, metastases to bone, and giant cell tumor of bone.

<span class="mw-page-title-main">Strontium ranelate</span> Chemical compound

Strontium ranelate, a strontium(II) salt of ranelic acid, is a medication for osteoporosis marketed as Protelos or Protos by Servier. Studies indicate it can also slow the course of osteoarthritis of the knee. The drug is unusual in that it both increases deposition of new bone by osteoblasts and reduces the resorption of bone by osteoclasts. It is therefore promoted as a "dual action bone agent" (DABA).

<span class="mw-page-title-main">Lasofoxifene</span> Chemical compound

Lasofoxifene, sold under the brand name Fablyn, is a nonsteroidal selective estrogen receptor modulator (SERM) which is marketed by Pfizer in Lithuania and Portugal for the prevention and treatment of osteoporosis and for the treatment of vaginal atrophy, and the result of an exclusive research collaboration with Ligand Pharmaceuticals (LGND). It also appears to have had a statistically significant effect of reducing breast cancer in women according to a study published in The Journal of the National Cancer Institute.

Senile osteoporosis has been recently recognized as a geriatric syndrome with a particular pathophysiology. There are different classification of osteoporosis: primary, in which bone loss is a result of aging and secondary, in which bone loss occurs from various clinical and lifestyle factors. Primary, or involuntary osteoporosis, can further be classified into Type I or Type II. Type I refers to postmenopausal osteoporosis and is caused by the deficiency of estrogen. While senile osteoporosis is categorized as an involuntary, Type II, and primary osteoporosis, which affects both men and women over the age of 70 years. It is accompanied by vitamin D deficiency, body's failure to absorb calcium, and increased parathyroid hormone.

An ovariectomized rodent (OVX) is a female rat or mouse whose ovaries have been removed. Currently, there is no single animal model that precisely replicates the stages of osteoporosis in humans, although there are some animals that are relatively close and can be used for comparative purposes. Both small and large animals are used depending on the specific aspects of the osteoporotic condition under investigation. Examples of such animals include rats, rabbits, and sheep.

Hormone replacement therapy (HRT), also known as menopausal hormone therapy or postmenopausal hormone therapy, is a form of hormone therapy used to treat symptoms associated with female menopause. Effects of menopause can include symptoms such as hot flashes, accelerated skin aging, vaginal dryness, decreased muscle mass, and complications such as osteoporosis, sexual dysfunction, and vaginal atrophy. They are mostly caused by low levels of female sex hormones that occur during menopause.

<span class="mw-page-title-main">Enobosarm</span> Investigational selective androgen receptor modulator

Enobosarm, also formerly known as ostarine and by the developmental code names GTx-024, MK-2866, and S-22, is a selective androgen receptor modulator (SARM) which is under development for the treatment of androgen receptor-positive breast cancer in women and for improvement of body composition in people taking GLP-1 receptor agonists like semaglutide. It was also under development for a variety of other indications, including treatment of cachexia, Duchenne muscular dystrophy, muscle atrophy or sarcopenia, and stress urinary incontinence, but development for all other uses has been discontinued. Enobosarm was evaluated for the treatment of muscle wasting related to cancer in late-stage clinical trials, and the drug improved lean body mass in these trials, but it was not effective in improving muscle strength. As a result, enobosarm was not approved and development for this use was terminated. Enobosarm is taken by mouth.

Romosozumab, sold under the brand name Evenity, is a medication used to treat osteoporosis. It has been found to decrease the risk of fractures of the spine.

<span class="mw-page-title-main">Eldecalcitol</span> Chemical compound

Eldecalcitol is an analog of calcitriol, the active form of vitamin D.

<span class="mw-page-title-main">Ligandrol</span> Chemical compound

LGD-4033, also known by the developmental code name VK5211 and by the black-market name Ligandrol, is a selective androgen receptor modulator (SARM) which is under development for the treatment of muscle atrophy in people with hip fracture. It was also under development for the treatment of cachexia, hypogonadism, and osteoporosis, but development for these indications was discontinued. LGD-4033 has been reported to dose-dependently improve lean body mass and muscle strength in preliminary clinical trials, but is still being developed and has not been approved for medical use. The drug is taken by mouth.

Recombinant human parathyroid hormone, sold under the brand name Preotact among others, is an artificially manufactured form of the parathyroid hormone used to treat hypoparathyroidism. Recombinant human parathyroid hormone is used in the treatment of osteoporosis in postmenopausal women at high risk of osteoporotic fractures. A significant reduction in the incidence of vertebral fractures has been demonstrated. It is used in combination with calcium and vitamin D supplements.

References

  1. 1 2 3 4 5 6 7 "Tymlos- abaloparatide injection, solution". DailyMed. 28 December 2021. Retrieved 14 October 2022.
  2. 1 2 3 4 5 6 "Eladynos EPAR". European Medicines Agency. 12 October 2022. Retrieved 3 March 2023.
  3. 1 2 Spreitzer H (18 January 2016). "Neue Wirkstoffe – Abaloparatid". Österreichische Apothekerzeitung (in German) (2/2016): 12.
  4. ↑ "Tymlos Subcutaneous Injection". accessdata.fda.gov. 8 June 2017. Retrieved 14 October 2022.
  5. 1 2 "Drug Trial Snapshot: Tymlos". U.S. Food and Drug Administration (FDA). 9 February 2019.PD-icon.svg This article incorporates text from this source, which is in the public domain .
  6. ↑ "FDA Approves Radius Health's Tymlos (abaloparatide), a Bone Building Agent for the Treatment of Postmenopausal Women with Osteoporosis at High Risk for Fracture" (Press release). Radius Inc. 28 April 2017. Archived from the original on 4 November 2017. Retrieved 3 November 2017.
  7. ↑ "FDA Approves Radius Health's Tymlos (abaloparatide), a Bone Building Agent for the Treatment of Postmenopausal Women with Osteoporosis at High Risk for Fracture" (Press release). Radius Health. 28 April 2017. Retrieved 3 March 2023– via GlobeNewswire.
  8. ↑ "Radius Health's Tymlos (abaloparatide) Receives U.S. FDA Approval as a Treatment to Increase Bone Density in Men with Osteoporosis at High Risk for Fracture". Radius (Press release). 21 December 2022. Retrieved 3 March 2023.
  9. ↑ Jolette J, Attalla B, Varela A, Long GG, Mellal N, Trimm S, et al. (June 2017). "Comparing the incidence of bone tumors in rats chronically exposed to the selective PTH type 1 receptor agonist abaloparatide or PTH(1-34)". Regulatory Toxicology and Pharmacology. 86: 356–365. doi: 10.1016/j.yrtph.2017.04.001 . PMID   28389324.
  10. ↑ Tella SH, Kommalapati A, Correa R (May 2017). "Profile of Abaloparatide and Its Potential in the Treatment of Postmenopausal Osteoporosis". Cureus. 9 (5): e1300. doi: 10.7759/cureus.1300 . PMC   5493470 . PMID   28680788.
  11. ↑ Pioszak AA, Parker NR, Gardella TJ, Xu HE (October 2009). "Structural basis for parathyroid hormone-related protein binding to the parathyroid hormone receptor and design of conformation-selective peptides". The Journal of Biological Chemistry. 284 (41): 28382–91. doi: 10.1074/jbc.M109.022905 . PMC   2788887 . PMID   19674967.
  12. ↑ Tay D, Cremers S, Bilezikian JP (February 2018). "Optimal dosing and delivery of parathyroid hormone and its analogues for osteoporosis and hypoparathyroidism - translating the pharmacology". British Journal of Clinical Pharmacology. 84 (2): 252–267. doi:10.1111/bcp.13455. PMC   5777439 . PMID   29049872.
  13. ↑ US Patent US 6,544,949 B1, "Analogs of Parathyroid Hormone", 8 April 2003, Inventor: Zheng Xin Dong
  14. ↑ Bahar H, Gallacher K, Downall J, Nelson CA, Shomali M, Hattersley G (November 2016). "Six Weeks of Daily Abaloparatide Treatment Increased Vertebral and Femoral Bone Mineral Density, Microarchitecture and Strength in Ovariectomized Osteopenic Rats". Calcified Tissue International. 99 (5): 489–499. doi:10.1007/s00223-016-0171-1. PMC   5055567 . PMID   27395059.
  15. ↑ Varela A, Chouinard L, Lesage E, Smith SY, Hattersley G (January 2017). "One Year of Abaloparatide, a Selective Activator of the PTH1 Receptor, Increased Bone Formation and Bone Mass in Osteopenic Ovariectomized Rats Without Increasing Bone Resorption". Journal of Bone and Mineral Research. 32 (1): 24–33. doi: 10.1002/jbmr.3003 . PMID   27748532.
  16. ↑ Varela A, Chouinard L, Lesage E, Guldberg R, Smith SY, Kostenuik PJ, Hattersley G (February 2017). "One year of abaloparatide, a selective peptide activator of the PTH1 receptor, increased bone mass and strength in ovariectomized rats". Bone. 95: 143–150. doi: 10.1016/j.bone.2016.11.027 . PMID   27894941.
  17. ↑ Clinical trial number NCT00542425 for "Phase 2 Dose-finding Study to Evaluate the Effects of BA058 in the Treatment of Postmenopausal Women With Osteoporosis" at ClinicalTrials.gov
  18. ↑ Leder BZ, O'Dea LS, Zanchetta JR, Kumar P, Banks K, McKay K, et al. (February 2015). "Effects of abaloparatide, a human parathyroid hormone-related peptide analog, on bone mineral density in postmenopausal women with osteoporosis". The Journal of Clinical Endocrinology and Metabolism. 100 (2): 697–706. doi: 10.1210/jc.2014-3718 . PMID   25393645.
  19. ↑ Clinical trial number NCT01343004 for "Phase III Study to Evaluate the Safety and Efficacy of BA058 for Prevention of Fracture in Postmenopausal Women" at ClinicalTrials.gov
  20. ↑ Miller PD, Hattersley G, Riis BJ, Williams GC, Lau E, Russo LA, et al. (August 2016). "Effect of Abaloparatide vs Placebo on New Vertebral Fractures in Postmenopausal Women With Osteoporosis: A Randomized Clinical Trial". JAMA. 316 (7): 722–33. doi: 10.1001/jama.2016.11136 . PMID   27533157.
  21. ↑ Clinical trial number NCT01657162 for "Twenty Four Month Extension Study of BA058-05-003" at ClinicalTrials.gov
  22. ↑ Cosman F, Miller PD, Williams GC, Hattersley G, Hu MY, Valter I, et al. (February 2017). "Eighteen Months of Treatment With Subcutaneous Abaloparatide Followed by 6 Months of Treatment With Alendronate in Postmenopausal Women With Osteoporosis: Results of the ACTIVExtend Trial". Mayo Clinic Proceedings. 92 (2): 200–210. doi: 10.1016/j.mayocp.2016.10.009 . PMID   28160873.
  23. 1 2 3 4 "Radius Health Reports Third Quarter 2017 Financial and Operating Results and Provides Business Update" (Press release). Radius Health. 2 November 2017. Retrieved 3 November 2017– via GlobeNewswire.
  24. ↑ "Radius Health Has Submitted a Marketing Authorization Application for the Investigational Drug Abaloparatide-SC for the Treatment of Postmenopausal Osteoporosis in Europe" (Press release). Retrieved 3 November 2017.
  25. ↑ "Radius Announces FDA Acceptance for Filing of New Drug Application for Abaloparatide-SC for the Treatment of Postmenopausal Women with Osteoporosis" (Press release). Retrieved 4 November 2017.
  26. ↑ "NDA Approval Letter". FDA. 27 April 2017.
  27. 1 2 "Eladynos: Pending EC decision". European Medicines Agency. 13 October 2022. Archived from the original on 14 October 2022. Retrieved 14 October 2022. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  28. ↑ "Eladynos Product information". Union Register of medicinal products. Retrieved 3 March 2023.
  29. ↑ "Abaloparatide". PharmaCompass.com. Retrieved 3 November 2017.
  30. ↑ The conversation (14 August 2024): Bone-building drug which prevents fractures in people with osteoporosis approved for use in UK – here’s how it works
  31. ↑ "Radius Health Announces License and Development Agreement for Abaloparatide-SC with Teijin Limited in Japan" (Press release). Retrieved 3 November 2017.
This page is based on this Wikipedia article
Text is available under the CC BY-SA 4.0 license; additional terms may apply.
Images, videos and audio are available under their respective licenses.