Drug manufacturer Novartis announced on August 20 that the US Food and Drug Administration (FDA) granted breakthrough therapy designation to BYM338 (bimagrumab) for treatment of sporadic inclusion body myositis (sIBM).
The designation is based on results of a phase 2 proof-of-concept study that showed BYM338 substantially benefited patients with sIBM compared with placebo. Investigators will present study results at the American Neurological Association meeting in October in New Orleans.
BYM338 (bimagrumab) is a human monoclonal antibody developed to treat pathological muscle loss and weakness. The drug, which is administered intravenously, binds with high affinity to type II activin receptors, preventing natural ligands from binding, including myostatin and activin. BYM338 stimulates muscle growth by blocking signaling from these inhibitory molecules.
The FDA created its breakthrough therapy designation to expedite the development and review of new drugs for serious or life-threatening conditions.