Sanofi, Regeneron Seek Fast-Track Reviews From EMA
Speedy Evaluations Requested For Avalglucosidase Alfa And Evinacumab
EU sponsors of two investigational drugs – one to treat the rare genetic Pompe disease and the other for patients with severe inherited form of high cholesterol – have requested a speedy review of their respective marketing applications.
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Kyowa Awaits EU Decision On Drug For Treating Parkinson’s ‘Off’ Time
The European Medicines Agency is meeting this week to decide whether two new drugs, including one that enhances anti-parkinsonian activity, should be approved for use in the EU. Also, the sponsor of a treatment for the rare degenerative muscle disorder, Pompe disease, is expected to attend an oral explanation meeting to address last-minute questions.
EU Accelerated Assessment Tracker
Sanofi failed in its attempt to have its EU marketing authorization application for avalglucosidase alfa fast-tracked through the centralized review process at the European Medicines Agency. This and other developments relating to the agency's accelerated assessment mechanism are logged in this latest update to the Pink Sheet's EU accelerated assessment tracker.
Sanofi Files New Pompe Hope Avalglucosidase Alfa In EU
The French drugmaker is looking to consolidate its dominance of the Pompe disease area by filing its successor to Myozyme in Europe, but Amicus Therapeutics' potential rival AT-GAA is on the horizon.