EU Approves Sanofi’s Xenpozyme and Nexviadyme

The European Commission has approved two Sanofi enzyme replacement therapies, Xenpozyme (olipudase alfa) and Nexviadyme (avalglucosidase alfa).

The commission granted a marketing authorization to Xenpozyme for treatment of non-central nervous system manifestations of acid sphingomyelinase deficiency (ASMD) in pediatric and adult patients with ASMD type A/B or ASMD type B. And it has authorized Nexviadyme for long-term treatment of both late-onset and infantile-onset Pompe disease.

The FDA granted a Breakthrough Therapy designation to olipudase alfa, but it has yet to approve the drug. Nexviadyme, branded as Nexviazyme in the U.S, is already FDA-approved for patients one year and older with late-onset Pompe disease.