Amylyx Pharmaceuticals

Albrioza, the approved treatment for amyotrophic lateral sclerosis (ALS) formerly known as AMX0035, is one giant step closer to being eligible for reimbursement under public drug plans in Canada, according to its developer, Amylyx Pharmaceuticals. Amylyx has reached an agreement with the pan-Canadian Pharmaceutical Alliance, or pcPA —…

Amylyx Pharmaceuticals is facing a new hurdle — a second round of questions from a European Medicines Agency (EMA) committee — in its quest to have AMX0035 approved as a treatment for amyotrophic lateral sclerosis (ALS) in Europe. The questions, from the Committee for Medicinal Products for…

A large Phase 3 trial designed to confirm the safety and efficacy of the approved therapy Relyvrio (sodium phenylbutyrate and taurursodiol) for amyotrophic lateral sclerosis (ALS) is now fully enrolled. Amylyx Pharmaceuticals announced the completion of patient recruiting for the trial, called PHOENIX (NCT05021536), which will…

AMX0035 — Amylyx Pharmaceuticals’ experimental combination therapy for amyotrophic lateral sclerosis (ALS) now under review for approval in the U.S. — alters the activity of genes involved in several disease-relevant pathways, according to a study in lab-grown cells. Notably, the two-compound oral treatment was seen to change the activity of many…

Note: This story was updated Aug. 10, 2022, to clarify the U.S. Food and Drug Administration advisory committee voted there is no substantial evidence supporting AMX0035 efficacy. When added to standard of care, both the experimental oral therapy AMX0035 and the U.S.-approved Radicava ORS oral suspension provide comparable…

Albrioza, an oral therapy for amyotrophic lateral sclerosis (ALS) still widely known as AMX0035, is now commercially available in Canada, its developer, Amylyx Pharmaceuticals, announced. Its market availability comes about 1.5 months after the therapy was conditionally approved by Health Canada for this neurodegenerative disease. The regulatory decision was based on…

Amylyx Pharmaceuticals has partnered with Sunnybrook Research Institute (SRI) to find new therapeutic candidates for amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases. Under terms of the two-year sponsored research agreement, SRI will work to identify potential therapeutics that potently and specifically inhibit Bax and Bak, two proteins…

A U.S. Food and Drug Administration (FDA) advisory committee will meet  Sept. 7 to discuss the approval of AMX0035 for the treatment of amyotrophic lateral sclerosis (ALS), Amylyx Pharmaceuticals announced. While the application was granted priority review earlier this year, with a final decision expected by June…

Albrioza, formerly called AMX0035, has been given conditional approval by Health Canada for the treatment of amyotrophic lateral sclerosis (ALS). The decision marks a first approval for Albrioza by a regulatory authority in any country and the first new ALS therapy to enter the Canadian market since 2018.

Note: This story was updated June 7, 2022, to note that CENTAUR is a Phase 2, not Phase 2/3, trial and that AMX0035 reduced the risk of death by 43%, instead of 44%. There also has been no indication that U.S. sites will open soon for the PHOENIX trial.