Novartis breakthough designation hat trick

Share this article:

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.

Share this article:
You must be a registered member of MMM to post a comment.
close

Next Article in Channel

MM&M EBOOK: PATIENT ACCESS

Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Channel

Five things for pharma marketers to know: Monday, September 15

Five things for pharma marketers to know: ...

Pharma has sought 76 meetings with FDA over biosimilars; Gilead licenses Sovaldi to India generic drugmakers; Pfizer and Ranbaxy Lipitor lawsuit dismissed.

Liraglutide, aiming for new indication, gets new name

Liraglutide, aiming for new indication, gets new name

Why Novo Nordisk is choosing not to leverage Victoza's brand equity as it seeks a weight-loss indication for liraglutide.

Five things for pharma marketers to know: Friday, September 12

Five things for pharma marketers to know: Friday, ...

An FDA panel voted in favor of liraglutide for weight loss; Allergan investors backing an attempted takeover of the firm crossed a critical threshold; and 100 million health wearables are ...