Partnership with leading US-based ALS patient advocacy group furthers myTomorrows’ mission of ensuring that patients confronting life-threatening diseases are aware of all possible treatment options
On behalf of everyone living with ALS and their families, the ALS Association sent a letter this week to members of the House and Senate demonstrating our support for the passing of the ALS Better Care Act which will increase access to multidisciplinary care clinics for people living with ALS.
The ALS Association, the largest ALS organization in the world, and NuvoAir, the leading value-based specialty care provider for heart and lung conditions, announced their partnership to support virtual pulmonary care for people living with ALS and their caregivers.
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 commends the FDA for approving tofersen under the agency’s accelerated approval pathway for the treatment of people living with ALS connected to mutations in the SOD1 gene. This marks the first time the FDA has approved a treatment for ALS under accelerated approval and serves as a promising endorsement of the antisense technology that underlies tofersen.
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.
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.
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.
Following the lack of action by the FDA to expedite approval of AMX0035, an experimental treatment for ALS, The ALS Association today called on the agency to follow its own guidance and move with the urgency of its Canadian and European Union counterparts. Health Canada and the European Medicines Agency (EMA) are working with Amylyx, the company that makes AMX0035, to move the treatment toward approval.