EC grants marketing authorisation for IntraBio’s Aqneursa

The European Commission (EC) has granted marketing authorisation for IntraBio’s Aqneursa to treat neurological symptoms of NPC. The authorisation covers combination use with miglustat, or as a single therapy if miglustat cannot be tolerated. The approval is supported by data from a Phase III randomised, double-blind, placebo-controlled, crossover study in NPC patients. Credit: Mongkolchon Akesin / Shutterstock.com. The European Commission (EC) has granted marketing authorisation for IntraBio’s Aqneursa (levacetylleucine) to treat neurological symptoms of Niemann-Pick disease type C (NPC). The decision follows a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency…

Source: Pharmaceutical Technology