ABIONYX Pharma receives positive EMA opinion for CER-001

ABIONYX Pharma announces a positive opinion from the European Medicines Agency (EMA) for its CER-001 treatment for LCAT deficiency. This decision is based on the acceptance of data from two manufacturing process validation batches. The submission, made on July 11, 2024, is part of a rolling review process that includes clinical and CMC data.

The EMA has validated the proposal to use these batches in the Marketing Authorization Application (MAA). ABIONYX will continue to develop viral safety and method validation until this submission. Eight European patients have already benefited from CER-001, the clinical basis of the MAA.