The U.S Food and Drug Administration (FDA) has increased the review time for Amylyx Pharmaceuticals Inc’s (NASDAQ: AMLX) experimental amyotrophic therapy for lateral sclerosis. This news led to a 0.22% drop in the company’s shares.
The new date that the FDA has set for the Prescription Drug User Fee Act is September 29, 2022. Amylyx’s stock has declined for the last three months by over 62.4%.
The change came after the company submitted additional data to the FDA
The FDA had initially granted priority review for the company’s oral drug, AMX0035, for June 29. However, this announcement shows that the regulator plans to postpone this by three months. This decision came after Amylyx submitted additional results from its trial. The FDA considered the new information a significant amendment to their additional agreement and stated that it would need more time to review the data.
According to the co-founders and co-CEOs of Amylyx, Joshua Cohen and Justin Klee, the company is confident in the drug’s ability to change the lives of people with ALS globally. Moreover, Amylyx will continue working with the agency regarding its decision on AMX0035.
The FDA’s advisory board advised against approving the drug
Before this extension, the FDA’s advisory committee had recommended the agency against endorsing the drug. About six of the committee’s members didn’t think that the CENTAUR Phase II study and its extension trial provided sufficient evidence for the efficacy of AMX0035.
The FDA often seeks the opinion of its advisory board before authorising a drug. While the regulator is not obligated to follow recommendations from the board, it tends to do so.
In this case, the FDA had raised similar concerns over AMX0035 as the company had used a small sample size, provided questionable statistical analysis, and had missing data. The agency requested that Amylyx provide more data from the PHOENIX Phase III study, which was larger before it could consider approving the treatment.
However, a petition that got 50,000 signatures swayed the regulator. The petition called for the drug to get quick approval. Other regulators in Europe and Canada are also reviewing the therapy. Amylyx is now enrolling patients for its PHOENIX Phase III study from different areas in Europe. It hopes to finish this study in 2024.