Rare EU Fast-Track Nod For Sanofi Genzyme's Olipudase Alfa
Product Is One Of Few To Secure Accelerated Assessment In Recent Months
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.
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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.
The Pink Sheet's EU accelerated assessment tracker has been updated to include developments relating to investigational products from Roche and CSL Behring/UniQure.
There have been some recent successes on the accelerated assessment front in the EU but more requests are rejected than granted.