The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for Genzyme's oral Aubagio (teriflunomide) for relapsing-remitting multiple sclerosis (MS).
Aubagio did not receive positive opinion from the committee concerning new active substance (NAS) designation.
Genzyme CEO and president David Meeker said the positive CHMP opinion and broad recommended marks strong clinical development program data of Aubagio.
"We are very disappointed about the CHMP opinion regarding new active substance designation. We believe based on the product's characteristics and current data that AUBAGIO is a new active substance," added Meeker.
The immunomodulator with anti-inflammatory properties, earlier received approval as relapsing MS therapy in the US and Australia.
Several regulatory bodies across the world are currently reviewing additional marketing applications related to the once-daily product.
