Af­ter an about-face on a PhI­II tri­al, FDA sets up an ad­comm to re­view con­tro­ver­sial ALS drug next month

Fol­low­ing a U-turn from the FDA, the agency’s Pe­riph­er­al and Cen­tral Ner­vous Sys­tem Drugs Ad­vi­so­ry Com­mit­tee will meet on March 30 for an all-day tele­con­fer­ence to dis­cuss what could be on­ly the third ALS drug ap­proved since 1995.

Al­though the po­ten­tial drug from Amy­lyx, known as AMX0035, may work, the FDA pre­vi­ous­ly sought an­oth­er tri­al to con­firm ear­ly pos­i­tive re­sults. The agency had asked Amy­lyx to con­duct a Phase III study last April to see whether Phase II da­ta from 2020 held up.

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