Below you'll find a list of all posts that have been categorized as “Advocacy”
RE: FDA-2022-N-0691 Dear FDA Advisory Committee: We write to express our strong support for the approval of tofersen under the FDA’s Accelerated Approval Program. Our organization’s long history of scientific research into SOD1-ALS and our depth of experience supporting people …
The FDA’s decision to approve Amylyx Pharmaceuticals’ therapeutic compound AMX0035 for treatment of ALS was fully justified by the data and the science. Clinicians, researchers, advocacy groups, and people living with ALS spoke in overwhelming numbers in favor of approval. …
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 …
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 …
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. …
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 …
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 …
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 …
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. …
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 …
