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Biopharma to request second look at approval.
Amylyx, a biopharmaceutical organization, has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has provided a negative opinion on its application for conditional marketing authorization of AMX0035 (sodium phenylbutyrate and ursodoxicoltaurine). Following clearance from the FDA and Health Canada, the company announced its intentions to seek re-examination of the application.
A second look will take up to approximately four months, which will reportedly the appointment of a different rapporteur and co-rapporteur from the initial evaluation.
“We are confident in the strength of our CENTAUR trial data, which we believe meets the criteria for conditional approval. These data were also the basis of the full approval received from the U.S. Food and Drug Administration and the approval with conditions from Health Canada,” said Tammy Sarnelli, global head, regulatory affairs, and clinical compliance at Amylyx. “We disagree with the CHMP’s opinion and will request a formal re-examination procedure of the current Marketing Authorization Application (MAA).”
Reference: Amylyx Pharmaceuticals Receives CHMP Negative Opinion on its Conditional Marketing Authorisation Application for AMX0035 for the Treatment of ALS in the European Union. Amylyx. June 23, 2023. Accessed June 26, 2023. https://www.amylyx.com/news/amylyx-pharmaceuticals-receives-chmp-negative-opinion-on-its-conditional-marketing-authorisation-application-for-amx0035-for-the-treatment-of-als-in-the-european-union