FDA hits Amicus with delay on 'breakthrough' Pompe drug
AT-GAA, Amicus Therapeutics’ lead Phase III drug for Pompe disease, was at the center of attention during the Q1 call with investors Monday. Execs talked about their high hopes for an approval by the July 29 PDUFA date, and analysts were asking questions about launch preparation.
The FDA, though, needs more time to make a decision.
Just after the market closed on Tuesday, Amicus put out word that the FDA has pushed back its review period by 90 days. The agency was dealing with two separate applications — a BLA for cipaglucosidase alfa and an NDA for miglustat — for the two components of AT-GAA, with PDUFA dates scheduled two months apart.
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