Bimagrumab

Last updated
Bimagrumab
Monoclonal antibody
Type ?
Source Human
Target ACVR2B
Clinical data
Other namesBYM338
ATC code
  • none
Identifiers
CAS Number
ChemSpider
  • none
UNII
KEGG
Chemical and physical data
Formula C6306H9732N1684O1990S46
Molar mass 142451.78 g·mol−1

Bimagrumab (BYM338) is a human monoclonal antibody developed by Novartis to treat pathological muscle loss and weakness. It binds to and inhibits activin receptor type-2B. [1]

Bimagrumab must be administered intravenously at a hospital or clinic. The medication has a long half life and is administered once a month. [2]

Development history

On August 20, 2013, it was announced that bimagrumab had received a breakthrough therapy designation for sporadic inclusion body myositis (sIBM) by the US Food and Drug Administration. [3]

In 2014, Bimagrumab entered Phase II development, with some research indicating clinical effects. [4] Novartis planned to apply in 2016 for FDA approval to treat sIBM patients with bimagrumab. [5]

In April 2016, Novartis announced that bimagrumab had failed a Phase IIb/III study for sporadic inclusion body myositis. [6] In January 2021, a new study confirmed that treatment with Bimagrumab is safe and effective for treating excess adiposity and metabolic disturbances of adult patients with obesity and type 2 diabetes. [7] In January 2023 the medication entered phase IIb trials for obesity. [2]

Related Research Articles

Inclusion body myositis (IBM) is the most common inflammatory muscle disease in older adults. The disease is characterized by slowly progressive weakness and wasting of both proximal muscles and distal muscles, most apparent in the finger flexors and knee extensors. IBM is often confused with an entirely different class of diseases, called hereditary inclusion body myopathies (hIBM). The "M" in hIBM is an abbreviation for "myopathy" while the "M" in IBM is for "myositis". In IBM, two processes appear to occur in the muscles in parallel, one autoimmune and the other degenerative. Inflammation is evident from the invasion of muscle fibers by immune cells. Degeneration is characterized by the appearance of holes, deposits of abnormal proteins, and filamentous inclusions in the muscle fibers. sIBM is a rare disease, with a prevalence ranging from 1 to 71 individuals per million.

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References

  1. Garito T, Zakaria M, Papanicolaou DA, Li Y, Pinot P, Petricoul O, et al. (June 2018). "Effects of bimagrumab, an activin receptor type II inhibitor, on pituitary neurohormonal axes". Clinical Endocrinology. 88 (6): 908–919. doi:10.1111/cen.13601. PMID   29566437. S2CID   5019650.
  2. 1 2 GlobalData Healthcare (2023-01-17). "Versanis' bimagrumab, first-in-class obesity therapy, enters Phase IIb of development". Pharmaceutical Technology. Retrieved 2023-05-27.
  3. "Novartis receives FDA breakthrough therapy designation for BYM338 (bimagrumab) for sporadic inclusion body myositis (sIBM)". Novartis AG. 23 August 2013. Archived from the original on 19 February 2014. Retrieved 20 August 2013.
  4. Amato AA, Sivakumar K, Goyal N, David WS, Salajegheh M, Praestgaard J, et al. (December 2014). "Treatment of sporadic inclusion body myositis with bimagrumab". Neurology. 83 (24): 2239–2246. doi:10.1212/WNL.0000000000001070. PMC   4277670 . PMID   25381300.
  5. "Novartis: Planned filings 2015 to >=2019" (PDF). Novartis Investor Presentation. 27 January 2015. Archived from the original (PDF) on 7 February 2015. Retrieved 27 May 2015.
  6. Carroll J (21 April 2016). "Novartis' 'breakthrough' muscle drug bimagrumab flunks a late-stage trial". Fierce Biotech.
  7. "Medication shows promise for weight loss in patients with obesity, diabetes". EurekAlert!. Retrieved 2021-01-20.