UPDATE: As of May 16, 2023, Medicare will formally cover wheelchair seat elevating systems for many types of power wheelchairs. We applaud this decision and are proud to have advocated for it. These systems are vital for those living with a disability. …
Comments from ALS Organizations United in Support of AMX0035 Approval
Submitted for FDA Advisory Committee hearing on September 7, 2022 Amyotrophic lateral sclerosis (ALS) is a horrific, neurodegenerative disease. At terrifying speed, ALS robs people of the ability to move, speak, eat, and breathe. It kills so quickly that people …
Submit Comments to FDA Advisory Committee on AMX0035 by August 23
The U.S. Food and Drug Administration (FDA) will hold a second public advisory committee meeting on September 7, 2022 to discuss new data about the safety and efficacy of AMX0035, a new treatment for ALS from Amylyx Pharmaceuticals. Following this …
Les Turner ALS Foundation CEO named to NIH ALS Strategic Plan Working Group
Andrea Pauls Backman, chief executive officer of the Les Turner ALS Foundation, has been invited by the U.S. National Institute of Neurological Disorders and Stroke (NINDS) to serve as a working group member on its ALS Strategic Planning Team and …
FDA grants priority review for new SOD1-ALS treatment
The U.S. Food and Drug Administration (FDA) has accepted a New Drug Application for tofersen, a drug in development by Biogen for treatment of superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS) – and granted priority review for the application. …
ALS Organizations Unite in Support of AMX0035 Approval
People living with ALS have no time to waste. The FDA must act urgently on new therapy approval. Amyotrophic lateral sclerosis (ALS) is a horrific neurodegenerative disease that affects over 30,000 Americans. It kills so swiftly that people with ALS …
Our Oral Testimony to the FDA Advisory Committee on the Approval of AMX0035
Open Public Hearing FDA Advisory Committee on AMX0035 March 30, 2022 Good afternoon. My name is Andrea Pauls Backman, CEO of the Les Turner ALS Foundation. My only disclosure is that the Les Turner ALS Foundation receives less than 2% …
Comments on Amylyx Pharmaceuticals’ New Drug Application for AMX0035
RE: Docket No. FDA-2018-N-0410 Dear FDA Advisory Committee: Founded in 1977, the Les Turner ALS Foundation is the oldest independent ALS group in the country. For 45 years, it has been our mission to provide the most comprehensive care and …
AMX0035 May Slow ALS Progression and Extend Life
On September 15, Amylyx Pharmaceuticals announced its intention to submit a New Drug Application to the FDA for AMX0035 for the treatment of ALS. If the New Drug Application is successful, AMX0035 would be only the third drug approved by …
