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:
close

Next Article in News

Email Newsletters

More in News

AstraZenca beefs up respiratory portfolio

AstraZenca beefs up respiratory portfolio

AstraZeneca has made an $875-million move to beef up its respiratory pipeline by making Almirall's lineup its own.

Amgen Q2 sales rise, company to lay off up to 2,900

Amgen Q2 sales rise, company to lay off ...

The majority of the layoffs will be in the US.

Doctors want to know how CMS plans to display Sunshine payment data

Doctors want to know how CMS plans to ...

Physician and industry trade groups are asking CMS to explain how context will be provided to the general public around the dollar sums drugmakers ascribe to doctors for things like ...