Sanofi Files New Pompe Hope Avalglucosidase Alfa In EU
Review Is Standard, Not Accelerated As Requested
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.
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Although Nexviadyme has been approved, the French group is still unhappy about the EMA's view that the Pompe disease therapy should not be classified as a new active substance.
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.
An advanced immunotherapy for recurrent glioblastoma and the first biosimilar version of Lucentis for age-related macular degeneration have also been submitted for review by the European Medicines Agency for potential pan-EU authorization.