RELYVRIO (previously known as AMX0035 in the U.S.) is an oral, fixed-dose combination therapy for the treatment of adults with ALS
Verdiperstat, Biohaven’s investigational first-in-class potent, selective, brain-penetrant, irreversible myeloperoxidase (MPO) enzyme inhibitor, failed to statistically differentiate from placebo in newly announced findings from the pivotal HEALEY ALS Platform Trial.
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.
12-month data show that earlier initiation of tofersen slowed decline across measures of clinical and respiratory function, strength, and quality of life
New PDUFA goal date scheduled for September 29, 2022 to allow time to review additional data
