Home » EU Approves Sanofi’s Xenpozyme and Nexviadyme
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.
Upcoming Events
-
07May
-
14May
-
30May