BioMarin Pharmaceuticals (BMRN) announces that Health Canada has approved Vimizim (elosulfase alfa) for long-term enzyme replacement therapy in patients with a confirmed diagnosis of mucopolysaccharidosis IVA (MPS IVA) or Morquio A syndrome, an ultra-rare disease with no cure.
A week after the FDA approved the use of BioMarin's (BMRN +5.4%) Vimizim for treating Morquio A syndrome, the European Medicines Agency has issued a positive opinion on BioMarin's EU marketing authorization application for selling the drug to treat Morquio A.
The recommendation will be referred to the EC, which is expected to render a final verdict on the matter in Q2.
BioMarin's (BMRN -0.5%) Vimizim becomes the 2nd treatment for Morquio A syndrome approved by the FDA this week. The nod isn't a surprise after nearly getting a near-unanimous thumbs up at the Ad Com two months ago.
Biomarin Pharmaceutical Inc develops and commercializes pharmaceuticals for serious diseases and medical conditions. Its product portfolio is comprised of five product candidates Naglazyme, Kuvan, Aldurazyme, VIMIZIM and Firdapse.