On behalf of everyone living with ALS and their families, the ALS Association sent a letter to CVS Caremark asking company to reconsider its current policy regarding coverage of Relyvrio.

The ALS Association submitted comments to the FDA’s Central and Peripheral Nervous System Advisory Committee, urging it to recommend approval of tofersen for people with ALS linked to a SOD1 gene mutation. The committee will meet virtually on March 22 to review data associated with Biogen’s new drug application.

The ALS Association filed a formal objection to health insurer CIGNA for the company’s decision to exclude Relyvrio from its formulary. In a letter also shared with the Centers for Medicare and Medicaid Services and the Veterans Administration, the Association called on CIGNA to reverse its decision.

The United States Department of Veterans Affairs has made RELYVRIO available for the treatment of ALS for veterans who are living with the disease who receive care at VA clinics or ALS specialists, becoming one of the first health care payers or insurers to provide access to the drug.

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.  

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.

The ALS Association filed formal objections with the Institute for Clinical and Economic Review, commonly known as ICER, over their flawed draft report on the cost-effectiveness of AMX0035 and oral edaravone.

This morning we joined other ALS organizations releasing an open letter urging the FDA to quickly approve AMX0035.

Today, ICER (the Institute of Clinical and Economic Review) issued its initial draft report on the cost-effectiveness of AMX0035 and oral edaravone.

We submitted a letter to the FDA signed by 37 clinicians who specialize in treating people with ALS calling on the FDA to swiftly approve AMX0035.

The ALS Association endorses the strengthened Accelerating Access to Critical Therapies for ALS Act (ACT) for ALS Act (H.R.8662/ S. 4867) as an important step in bringing promising new treatments to people with ALS as quickly as possible. The bill accelerates the fight against ALS by authorizing $100 million for ALS research and creating the first federal entity explicitly charged with developing treatments for neurodegenerative diseases.

The ALS Association strongly supports initiatives to enable people with ALS to access promising treatments as soon as possible, including prior to FDA approval. Our primary goal is to facilitate the development of effective treatments and help support delivery to everyone with ALS as soon as possible.