Zurich: Novartis said on Tuesday U.S. regulators have granted breakthrough therapy status for its investigational compound bimagrumab for the potential treatment of patients with sporadic inclusion body myositis (sIBM).
The U.S. Food and Drug Administration (FDA) created the "breakthrough therapy" designation earlier this year for medicines deemed likely to demonstrate "substantial improvement" over existing drugs.
sIBM is a rare yet potentially life-threatening muscle-wasting condition. Patients suffering from the disease can gradually lose the ability to walk. There are currently no approved treatments, according to Novartis.
Bimagrumab was developed by Novartis in collaboration with Morphosys. The drug works by stimulating muscle growth by blocking from inhibitory molecules.