Genentech’s New NMOSD Drug Offers At-Home Treatment, Lower Cost
List price is below competitors from Alexion, Viela Bio
Enspryng (satralizumab) is the third FDA-approved drug but only at-home treatment for neuromyelitis optica spectrum disorder; significant percentage of patients are not being treated.
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Influence of expedited review pathways and regulatory incentives is on display in 2020’s novel approvals, which have a composition reassuringly consistent with recent years.
Viela and Roche both now have marketing applications that are being reviewed by the European Medicines Agency. If approved in the EU, their products will compete with Alexion’s blockbuster Soliris.
Keeping Track: US FDA Has Clinical Questions For Tricida, Gilead And BioMarin; Enspryng And Winlevi Approved
The latest drug approval and decision news from the Pink Sheet’s US FDA Performance Tracker.