FDA to Decide on AT-GAA for Late-onset Pompe Around Mid-2022

FDA to Decide on AT-GAA for Late-onset Pompe Around Mid-2022

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FDA to Decide on AT-GAA for Late-onset Pompe Around Mid-2022

The U.S. Food and Drug Administration (FDA) is reviewing applications from Amicus Therapeutics asking for the approval of AT-GAA as a treatment for late-onset Pompe disease (LOPD). Amicus initiated a rolling application for AT-GAA late last year, which allowed the company to submit portions of its application as they became ready, instead of a waiting until all data was available as is standard. The company now announced that it completed two applications covering each component of the…

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