Novartis gains breakthrough therapy designation for sIBM drug from US FDA

Swiss drug major Novartis (NOVN: VX) has gained US Food and Drug Administration breakthrough therapy designation for its compound BYM338 (bimagrumab) for sporadic inclusion body myositis (sIBM).

Breakthrough therapy designation was created by the FDA to expedite the development and review of new drugs for serious or life-threatening conditions. This designation is based on the results of a Phase II proof-of-concept study that showed BYM338 substantially benefited patients with sIBM compared to placebo.

SIBM is a rare yet 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, or established, treatment options for sIBM.