By Adriano Marchese
Amylyx Pharmaceuticals said its treatment for amytrophic lateral sclerosis has received a negative opinion from European Union regulators.
The biopharmaceutical company said the European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a negative opinion of its application for the conditional marketing authorization of its ALS treatment AMX0035 under the trade name Albrioza.
In May, Amylyx said it was aware that the committee was trending toward a negative opinion on AMX0035.
Despite the negative opinion, the company said it remains confident in the strength of its AMX0035 trial data, which it believes meets the criteria for conditional approval.
Amylyx added that the same AMX0035 trial data was also used to form the basis for full approval it received from the U.S. Food and Drug Administration and for conditional approval from Health Canada.
“We disagree with the CHMP’s opinion and will request a formal re-examination procedure of the current Marketing Authorisation Application,” Global Head of Regulatory Affairs and Clinical Compliance Tammy Sarnelli said.
Write to Adriano Marchese at [email protected]
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