Amylyx says European Medicines Agency may spike ALS drug Relyvrio
The European Medicines Agency (EMA) is leaning towards not approving Relyvrio, Amylyx Pharmaceuticals’ amyotrophic lateral sclerosis (ALS) drug, the company announced Tuesday.
A negative opinion from the regulatory agency would be a major setback for Amylyx, which has been pushing for a European approval for Relyvrio after winning approvals in both the U.S. and Canada.
In September, the Food and Drug Administration (FDA) approved Relyvrio amid controversy over its clinical benefit. That approval was based on results from the CENTAUR clinical trial, which showed a statistically significant benefit in function, as well as an observed benefit on survival in a long-term analysis, Amylyx said.
However, at the moment, the Committee for Medicinal Products for Human Use (CHMP), part of EMA, is leaning towards a ‘no’ on Relyvrio’s application. The EMA is expected to decide on Relyvrio’s approval sometime in June.
“We disagree with the current view expressed by the CHMP and remain confident in the data from the CENTAUR trial,” Tammy Sarnelli, global head of regulatory affairs and clinical compliance at Amylyx, said in a statement. “Should a negative opinion ultimately be issued, we intend to request a formal re-examination procedure.”
