|Chemical and physical data|
|Molar mass||142.4 kDa g·mol−1|
Bimagrumab (BYM338) is a human monoclonal antibody developed by Novartis to treat pathological muscle loss and weakness. On August 20, 2013 it was announced that bimagrumab was granted breakthrough therapy designation for sporadic inclusion body myositis (sIBM) by US Food and Drug Administration.
Bimagrumab is currently entering Phase II development, with some research indicating clinical effects. In 2016, Novartis intends to apply for FDA approval to treat sIBM patients with Bimagrumab BYM338.
April 2016 Novartis said that its “breakthrough” drug bimagrumab (BYM338) failed a Phase IIb/III study for sporadic inclusion body myositis.
- "Novartis receives FDA breakthrough therapy designation for BYM338 (bimagrumab) for sporadic inclusion body myositis (sIBM)". Retrieved 20 August 2013.
- Amato, AA; Sivakumar, K; Goyal, N; David, WS; Salajegheh, M; Praestgaard, J; Lach-Trifilieff, E; Trendelenburg, AU; Laurent, D; Glass, DJ; Roubenoff, R; Tseng, BS; Greenberg, SA. "Treatment of sporadic inclusion body myositis with bimagrumab". Neurology. 83: 2239–46. doi:10.1212/WNL.0000000000001070. PMC 4277670. PMID 25381300.
- Novartis: Planned filings 2015 to >=2019. Retrieved 27 May 2015.
- Novartis’ ‘breakthrough’ muscle drug bimagrumab flunks a late-stage trial
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