FDA needs three more months to review Roche's SMA drug — giving Biogen, Novartis some relief
The first oral drug for spinal muscular atrophy was widely expected to be approved by the end of May after priority review. But its developers at Roche, PTC Therapeutics and the SMA Foundation will now have to wait for three more months.
The FDA said they need the extra time to review a bunch of new data Roche has recently submitted, including results from a trial involving older patients. The good news is that regulators have identified “no substantive review issues” to date, according to a PTC statement.
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