Topline data from the Phase III PHOENIX trial of Relyvrio, which won approval in 2022, showed no significant difference on either the primary or secondary endpoints, according to Amylyx.
Tag Archive for: Amylyx
Pharma companies are striving to convey the true impact of diseases on patients while continuing to empower them.
The past year has seen incremental victories in the neurodegenerative disease space with the approval of Amylyx’s Relyvrio, in ALS and Biogen and Eisai’s Leqembi (lecanemab) in Alzheimer’s disease. Despite these regulatory milestones, there are still hurdles to overcome, with delivery across the blood-brain barrier topping the list.
The FDA might only have two PDUFA dates on the calendar this week, but all eyes in the neurodegenerative disease community will be on the first one: Amylyx’s AMX0035 for ALS.
The agency will reconvene a meeting of its outside experts to review the company’s application seeking approval for its amyotrophic lateral sclerosis (ALS) treatment.
