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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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.
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.
With Roche's oral spinal muscular atrophy therapy Evrysdi off to a strong start after its recent US launch, Novartis is switching its priorities for rival RNA-splicing drug branaplam and putting it into a Phase IIb trial for Huntington's disease.