"Breakthrough Therapy" Status Could Hasten Novartis Drug Review
The Food and Drug Administration has granted "breakthrough therapy" status for Novartis' BYM338 drug, the company announced today, which could hasten regulatory review.
The drug is designed to treat a rare form of a potentially life-threatening muscular deterioration disease called sporadic inclusion body myositis (sIBM), Novartis said in its statement. At this time, according to Novartis, there are no existing treatments for sIBM, the symptoms of which can include losing the ability to walk, loss of hand function, and difficulty in swallowing.
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 plans to present results from the study in October at an American Neurological Association meeting.
BYM338 is the third drug this year that has received breakthrough therapy status from the FDA, Novartis said.
FDA breakthrough status "is intended to expedite the development and review of drugs for serious or life-threatening conditions," according to the FDA. Novartis said the breakthrough therapy status leads to more intensive FDA interaction and guidance for the drugmaker than simply a fast-track designation, which also is designed to speed up the approval of drugs that treat life-threatening diseases.
-- Material from The Associated Press was used in this report.
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