Amylyx Pharmaceuticals, Inc.’s drug AMX0035 for treatment of amyotrophic lateral sclerosis will not be following the approval pathway of Aduhelm, at least not based on a surrogate endpoint. US Food and Drug Administration officials noted at an advisory committee meeting that there is no established biomarker for AMX0035 but that it would have been helpful to “the contextual picture” if AMX0035 had been shown to have an impact on a promising potential biomarker.
The agency granted accelerated approval for Biogen, Inc./Eisai Co., Ltd.'s Aduhelm (aducanumab) based on a single positive Phase...