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Sanofi Bags EU Approvals But Fumes At Regulator

Green Lights For Nexviadyme And Xenpozyme

 
• By Kevin Grogan

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
• Source: Sanofi

Sanofi is celebrating a pair of regulatory successes in the EU for drugs that the French group hopes will become standards of care for Pompe disease and acid sphingomyelinase deficiency (ASMD), while issuing a stinging broadside to the European Medicines Agency, claiming it has undermined rare disease incentive mechanisms.

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