Sanofi Posts More Positive Olipudase Alfa Data As Approval Decisions Loom
First Potential Therapy For Rare Lysosomal Storage Disease
Ahead of a PDUFA date of 3 July, Sanofi has added to the body of clnical evidence supporting olipudase alfa as a treatment for acid sphingomyelinase deficiency (ASMD), a rare, progressive and potentially life-threatening disease with no approved therapies.
You may also be interested in...
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
CEO Paul Hudson tells Scrip that in an atopic dermatitis market that has a standard of care like Dupixent, "it's hard to justify the role of a JAK unless somebody has, frankly, failed everything else."
Sanofi argues that the European Medicines Agency applies a narrow interpretation of its new active substance principles which is not appropriate for biological therapies, and that the regulator fails to consider the challenges of conducting clinical research in rare diseases.