Watch our oral testimony at the FDA Advisory Committee meeting on September 7, 2022. We are grateful to the FDA Advisory Committee for examining the evidence, listening to the ALS community, and voting to recommend approval of Amylyx Pharmaceuticals’ therapeutic …
Oral Testimony to the FDA Advisory Committee on the Approval of AMX0035
Delivered by Andrea Pauls Backman, CEO of the Les Turner ALS Foundation. Slides can be seen here (PDF). Open Public Hearing FDA Advisory Committee on AMX0035 September 7, 2022 Good afternoon. My name is Andrea Pauls Backman, CEO of the …
Comments to Centers for Medicare & Medicaid Services on Seat Elevation Systems as an Accessory to Power Wheelchairs
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. …
We’re in it Together at the ALS Walk for Life!
The ALS Walk for Life, which will take place on Saturday, September 24 at Soldier Field, brings together thousands of walkers to create ALS awareness and raise much-needed funds for ALS care and research. But it also creates something else …
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 …
New results show promise in treatment of SOD1-ALS
New results from the Phase 3 clinical trial of tofersen, a drug in development by Biogen, have shown promise in treatment of superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS). According to the 12-month data, earlier initiation of treatment with …
