The ALS Association recently sent letters to 43 of the largest insurance companies and health care payers to make RELYVRIO, which was formerly developed as AMX0035 and approved by the FDA for use in the treatment of ALS in September, available and accessible for people living with ALS.
Biogen Inc. announced that the U.S. Food and Drug Administration extended the review period of the promising gene therapy treatment Tofersen to consider additional data. The initial review period, which was announced in July 2022, was scheduled to conclude in January 2023. The review will now be extended to April 25, 2023.
The U.S. Food and Drug Administration awarded $3.7 million to three ALS research projects as part of the implementation of the Accelerating Access to Critical Therapies for Amyotrophic Lateral Sclerosis Act (ACT for ALS).
The ALS Association, the country’s largest nonprofit committed to making ALS livable and finding a cure, today celebrated the Food and Drug Administration’s (FDA) approval of AMX0035, a new treatment for people living with amyotrophic lateral sclerosis (ALS), a fatal neurodegenerative disease. The Association invested $2.2 million of funds raised through the 2014 ALS Ice Bucket Challenge into the development and trial of AMX0035, and led the years-long advocacy campaign that pushed the FDA to approve the treatment prior to completion of an ongoing phase 3 trial.
An FDA advisory committee voted overwhelmingly (7-2) to support approval of AMX0035 for the treatment of ALS. A phase 3 clinical trial will continue to test the effectiveness of AMX0035.
Earlier today the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee voted 6 to 4 against recommending AMX0035 for approval to treat people with ALS. It’s important to note that the Advisory Committee’s views are not binding on the FDA. Following the vote, the ALS Association called on the FDA to take into account the strong safety profile of AMX0035, as well as the serious unmet medical need of people living with this devastating condition, and approve the drug for clinical use.