Amylyx Pharmaceuticals gets RELYVRIO FDA approval for ALS
RELYVRIO FDA approval for ALS : Amylyx Pharmaceuticals has secured approval for RELYVRIO (sodium phenylbutyrate and taurursodiol) from the US Food and Drug Administration (FDA) has approved for the treatment of amyotrophic lateral sclerosis (ALS) in adults.
RELYVRIO, which is an oral, fixed-dose medication, can be taken either as a monotherapy or with currently approved treatments for ALS, which is commonly called Lou Gehrig’s disease.
Joshua Cohen and Justin Klee — Co-CEOs of Amylyx Pharmaceuticals, commenting on RELYVRIO FDA approval for ALS, said: “Today’s FDA approval of RELYVRIO is an exciting milestone for the ALS community and is a major step toward achieving our mission to one day end the suffering caused by neurodegenerative diseases.
“We want to give a heartfelt thank you to the broader ALS community, including healthcare professionals and those living with ALS, for their guidance, support of our clinical programs, and for sharing their experiences with us. Their stories inspired us and helped our team to better understand the ALS clock, instilling in us a deep sense of urgency that will continue to drive us forward.”
RELYVRIO FDA approval for ALS was driven by the findings of the phase 2 CENTAUR clinical trial that featured 137 patients with the disease.
Billy Dunn — FDA Center for Drug Evaluation and Research director of the Office of Neuroscience said: “This approval provides another important treatment option for ALS, a life-threatening disease that currently has no cure.
“The FDA remains committed to facilitating the development of additional ALS treatments.”
Previously called AMX0035 in the US, RELYVRIO considerably slowed the loss of physical function in ALS patients in the randomized, placebo-controlled clinical trial, said the Massachusetts-based Amylyx Pharmaceuticals.