FDA labels Novartis drug a 'breakthrough therapy'

FDA labels potential Novartis drug for muscle-wasting condition a 'breakthrough therapy'

Associated Press

Swiss drug developer Novartis said Tuesday that its potential treatment for a rare muscle-wasting disease received a "breakthrough therapy" designation from U.S. regulators, which will speed up final testing and review.

The drug, labeled BYM338, aims to treat sporadic inclusion body myositis, a potentially life-threatening condition in which patients can experience falls, gradually lose the ability to walk and have trouble swallowing. There are currently no approved treatments.

Novartis said that while the condition is rare, it also is the most common degenerative muscle disease in adults older than 65.

The Novartis treatment stimulates muscle growth. Patients who took it during midstage testing "substantially benefited" compared with those taking a placebo, the drugmaker said. Novartis will present results from the study in October at an American Neurological Association meeting.

Novartis said the breakthrough therapy status leads to more intensive FDA interaction and guidance for the drugmaker than a fast track designation, which also is designed to speed up the approval of drugs that treat life-threatening diseases.

U.S.-traded shares of Novartis closed at $72.90 on Monday and have climbed about 15 percent so far this year.