Tuesday, August 20, 2013

Novartis gets USFDA breakthrough designation for BYM338 (bimagrumab) for sporadic inclusion body mysoitis

Novartis has received FDA breakthrough therapy designation for BYM338 (bimagrumab) - A drug for treating sufferers of sporadic inclusion body myositis (sIBM), a rare yet potentially fatal muscle-wasting condition.
  • If eventually authorized, BYM338 has the potential to become the first treatment for sIBM.
  • BYM338 is the third Novartis drug this year to obtain the FDA's breakthrough designation. The company developed it with Morphosys
  • Patients with sIBM can gradually lose their ability to walk, experience falls and injuries, lose hand function, and have swallowing difficulties 
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. The results of this study will be presented at the American Neurological Association meeting on October 14 and is expected to be published in a major medical journal later this year.

About BYM338 (bimagrumab) and the Novartis commitment to research in muscle therapeuticsBYM338 (bimagrumab) is a novel, fully human monoclonal antibody developed to treat pathological muscle loss and weakness. BYM338 was developed by the Novartis Institutes for Biomedical Research (NIBR), in collaboration with Morphosys, whose HuCAL library was used to identify the antibody. BYM338 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. 

In addition to being developed for sIBM, BYM338 is in clinical development for chronic obstructive pulmonary disease (COPD), cancer cachexia, sarcopenia and in mechanically ventilated patients. BYM338 is administered by intravenous infusion. 


Enter your email address:


Delivered by FeedBurner