Posted by Michael Wonder on 28 Aug 2018
Ultragenyx announces approval of Mepsevii (vestronidase alfa) in Europe for the treatment of mucopolysaccharidosis VII
27 August 2018 - Mepsevii, an enzyme replacement therapy, is the first treatment approved in the EU for mucopolysaccharidosis VII.
Ultragenyx today announced that the European Commission has approved the marketing authorisation application for Mepsevii™ (vestronidase alfa), for the treatment of non-neurological manifestations of Mucopolysaccharidosis VII (MPS VII; Sly syndrome). Mepsevii is now approved for use in all 28 EU countries and in Iceland, Liechtenstein and Norway.
The approval follows a positive opinion adopted on 28 June 2018 by the European CHMP to recommend approval of Mepsevii under exceptional circumstances. The EMA granted orphan drug designation to Mepsevii in March 2012. Mepsevii was approved by the U.S. FDA for the treatment of paediatric and adult patients with MPS VII in November 2017.
