Phase 3 PHOENIX trial

Relyvrio (sodium phenylbutyrate and taurursodiol), an approved treatment for amyotrophic lateral sclerosis (ALS), was voluntarily removed from the U.S. and Canadian markets. Amylyx Pharmaceuticals, the therapy’s developer, made the decision after top-line results from the Phase 3 PHOENIX trial (NCT05021536) showed that patients who received Relyvrio…

An advisory committee of the European Medicines Agency has maintained its recommendation not to approve AMX0035 for amyotrophic lateral sclerosis (ALS). In its initial assessment issued in June, the Committee for Medicinal Products for Human Use (CHMP) said data from the CENTAUR Phase 2 trial (NCT03127514), which formed…

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.

The U.S. Food and Drug Administration (FDA) has accepted for review Amylyx Pharmaceuticals‘ application seeking approval of AMX0035 for the treatment of amyotrophic lateral sclerosis (ALS). The new drug application (NDA) also was granted priority review by the regulatory agency, which reduces review time from the standard…

Amylyx Pharmaceuticals‘ global Phase 3 clinical trial investigating AMX0035 as an oral treatment for amyotrophic lateral sclerosis (ALS) has begun dosing participants. The PHOENIX trial (NCT05021536) is expected to include 600 participants whose symptoms began in the past two years, which is a less-stringent criteria than was required for…