Novartis landed a breakthrough designation hat trick Tuesday when the FDA bestowed the label on the Swiss company’s experimental drug BYM338, also known as bimagrumab. Tuesday’s announcement is the third time the company has won this designation for its treatments. The label was granted for the muscle-wasting disease sporadic inclusion body myositis. The rare disease can be deadly. The US and EU granted the drug orphan status last year for this condition. Novartis will release Phase II clinical trial data at the October American Neurological Association meeting.
The drug maker is also testing the infusion treatment for COPD, cancer cachexia and sarocepenia.
The breakthrough designation has become a critical label in the first 8 months that it has been in effect. Johnson & Johnson estimates that the label has shaved two years off development for its experimental oncology drug Ibrutinib, as noted by Reuters earlier this summer.
