12-month data show earlier initiation of tofersen slowed decline across critical measures of function and strength in people diagnosed with SOD1-ALS
Amylyx Pharmaceuticals announced that the donated clinical data from the placebo arm of the CENTAUR clinical trial that evaluated the safety, efficacy, and survival benefits of AMX0035 in adult participants with amyotrophic lateral sclerosis (ALS) are now available in the Pooled Resource Open-Access ALS Clinical Trials (PRO-ACT) database.
On September 7 the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee, comprised of independent advisers to the FDA, voted 7—2 in favor of recommending AMX0035 for approval. The Advisory Committee’s recommendation is not binding. The FDA is expected to decide whether to approve AMX0035 by September 29.
Biogen Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) for tofersen, an investigational drug for superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS).
The HEALEY ALS Platform Trial led by the Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital in collaboration with the Northeast ALS Consortium (NEALS) is a trial in which multiple investigational products are tested and evaluated simultaneously to accelerate the development of potential new therapies for people with ALS.
Albrioza (formerly AMX0035) was approved by Health Canada for ALS this week. NEALS sites and members were leaders of the CENTAUR trial of Albrioza.
New PDUFA goal date scheduled for September 29, 2022 to allow time to review additional data
12-month data show that earlier initiation of tofersen slowed decline across measures of clinical and respiratory function, strength, and quality of life
Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced the U.S. Food and Drug Administration (FDA) has approved RADICAVA ORS® (edaravone), the oral form of edaravone, for the treatment of amyotrophic lateral sclerosis (ALS), a neurodegenerative disease that currently has no cure and can progress rapidly.
Coya Therapeutics, Inc. (“Coya), a privately held clinical-stage biotechnology company developing first-in-class approaches utilizing autologous regulatory T cells (Treg) and Treg-derived exosome therapeutics for neurodegenerative and autoimmune diseases, today announced the publication of results from a Phase 1 trial entitled “Tregs Attenuate Peripheral Oxidative Stress and Acute Phase Proteins in ALS.”
