Monoclonal antibody | |
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Type | ? |
Source | Human |
Target | ACVR2B |
Clinical data | |
Other names | BYM338 |
ATC code |
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Identifiers | |
CAS Number | |
ChemSpider |
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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]
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]
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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