The FDA granted breakthrough therapy designation to Novartis' experimental drug bimagrumab, also known as BYM338, for sporadic inclusion body myositis (sIBM), the company reported Tuesday. Timothy Wright, global head of development at Novartis Pharmaceuticals, remarked "with no effective therapies currently available for sIBM, bimagrumab has the potential to be the first real option for patients with this condition."
According to the drugmaker, the designation was based on Phase II study results showing that bimagrumab substantially benefited patients with sIBM compared to placebo. Novartis indicated that data from the trial will be presented at the American Neurological Association meeting in October.
Bimagrumab, which received orphan drug designation in sIBM in both the US and Europe last year, was developed in collaboration with MorphoSys. The intravenous drug is designed to stimulate muscle growth by blocking signalling from inhibitory molecules that bind to type II activin receptors. Novartis is also developing bimagrumab for chronic obstructive pulmonary disease, cancer cachexia, sarcopenia and in mechanically ventilated patients.
Novartis has also received FDA breakthrough therapy status for LDK378 for the treatment of patients with ALK-positive, metastatic non-small-cell lung cancer, as well as for serelaxin, also known as RLX030, for the treatment of patients with acute heart failure.