Watch our oral testimony at the FDA Advisory Committee meeting on March 22, 2023. We are grateful to the FDA Advisory Committee for reviewing the evidence, listening to the ALS community and voting to recommend accelerated approval of tofersen for …
Oral Testimony to the FDA Advisory Committee on the Approval of tofersen
Delivered by Lauren Webb, LCSW, Chief Advocacy and Outreach Officer of the Les Turner ALS Foundation. See also remarks by Senda Ajroud-Driss, MD, Director of the Lois Insolia ALS Clinic at the Les Turner ALS Center at Northwestern Medicine. Open …
Call for Comments: Proposed Decision on Medicare & Seat Elevation Systems
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 to the FDA Advisory Committee in Support of Tofersen Approval
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 …
FDA Approves AMX0035 (RELYVRIO™) for Treatment of ALS
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. …
FDA Advisory Committee Recommends Approval of AMX0035
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. …
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 …
