FDA Filing of AT-GAA for Late-onset Pompe Expected by Mid-Year

FDA Filing of AT-GAA for Late-onset Pompe Expected by Mid-Year

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FDA Filing of AT-GAA for Late-onset Pompe Expected by Mid-Year

Amicus Therapeutics anticipates completing a rolling application by mid-year to seek approval of its investigational therapy AT-GAA for late-onset Pompe disease in the U.S. The announcement follows a pre-filing meeting with the U.S. Food and Drug Administration (FDA). The rolling biologics license application (BLA), initiated in December 2020, allows Amicus to submit completed sections of the application as soon they are ready, instead of waiting to file the entire document at once, as is typically…

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