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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Its crunch time for sponsors of more than a dozen products as the EMA meets to adopt opinions on several marketing authorization applications.
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.