BioCentury
ARTICLE | Clinical News

Vimizim elosulfase alfa regulatory update

November 18, 2013 8:00 AM UTC

The French National Agency for Medicines and Health Products Safety (ANSM) granted an Authorization of Temporary Use (ATU) for BioMarin's Vimizim elosulfase alfa to treat mucopolysaccharidosis IVA (MPS-IVA, Morquio's syndrome). The authorization allows patients in France to receive Vimizim before EU approval. An MAA for Vimizim is under review in Europe, with a recommendation from EMA's CHMP expected late this year or early next year. Last month, BioMarin disclosed in its 3Q13 earnings that EMA changed the review status for the MAA to a standard assessment from an accelerated assessment. An accelerated assessment would have shortened the review period to 150 days from 210 (see BioCentury, Oct. 28). ...