FDA Reverses on Amicus, Allows It To File Fabry Drug

Jul 11, 2017

Amicus have announced that the U.S. Food and Drug Administration is reversing a decision from last November that would have delayed its Fabry drug treatment's approval until 2019 or 2020. The FDA requested an additional Phase 3 study for migalastat, the treatment of the rare Fabry disease disorder.

According to Amicus, it is aiming to file a new drug application by the end of 2017 and hopes for an approval within six months.

Magalastat was approved in the European Union in 2016, but the FDA had been holding off Amicus's application because two of its clinical trials failed to meet their goals.

Amicus was able to convince the FDA to review the data using new analysis methods, leading to its ability to file later this year.

The full approval process must still be undertaken and the FDA could still ultimately reject the drug.

Read the Forbes report