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Muscle-Wasting Drug Bimagrumab Gets ‘Breakthrough Therapy’ Designation
The FDA has granted a breakthrough therapy designation to bimagrumab (BYM338, Novartis) for the treatment of sporadic inclusion-body myositis (sIBM).
sIBM is a rare but potentially life-threatening muscle-wasting condition. Patients who have the disease can gradually lose the ability to walk, experience falls and injuries, lose hand function, and have swallowing difficulties. There are no currently approved treatment options for the disorder.
The FDA created the breakthrough therapy designation to expedite the development and review of new drugs for serious or life-threatening conditions. The designation for bimagrumab is based on the results of a phase II proof-of-concept study, which showed that the drug substantially benefited patients with sIBM compared with placebo. The study results will be presented Oct. 14 at the American Neurological Association meeting.
Bimagrumab is a fully human monoclonal antibody developed to treat pathological muscle loss and weakness. The drug binds with high affinity to type II activin receptors, thereby preventing natural ligands, including myostatin and activin, from binding. Bimagrumab stimulates muscle growth by blocking signaling from these inhibitory molecules.
Source: Novartis; August 20, 2013.