Rare EU Fast-Track Nod For Sanofi Genzyme's Olipudase Alfa
Product Is One Of Few To Secure Accelerated Assessment In Recent Months
Executive Summary
Only three planned marketing authorization applications are known to have been granted accelerated assessment status by the European Medicines Agency between July and October this year.
You may also be interested in...
AstraZeneca/Sanofi’s RSV Shot Among 13 Hopefuls Awaiting EU Verdict
Its crunch time for sponsors of more than a dozen products as the EMA meets to adopt opinions on several marketing authorization applications.
Sanofi Posts More Positive Olipudase Alfa Data As Approval Decisions Loom
Ahead of a PDUFA date of 3 July, Sanofi has added to the body of clinical evidence supporting olipudase alfa as a treatment for acid sphingomyelinase deficiency (ASMD), a rare, progressive and potentially life-threatening disease with no approved therapies.
EU Accelerated Assessment Tracker
The Pink Sheet's EU accelerated assessment tracker has been updated to include developments relating to investigational products from Roche and CSL Behring/UniQure.