Sanofi Stunned As FDA Says No To CAD Drug Sutimlimab
Deficiencies At Third-Party Manufacturing Facility
The French major's hopes for launching its rare blood disorder drug sutimlimab soon have been scuppered by a complete response letter from the FDA after inspecting a third-party facility responsible for making the first-in-class therapy.
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Join us for a brief audio tour around the past week's key developments in the global biopharma industry, in this podcast version of Scrip's Five Must-Know Things.
The French drugmaker's follow up to Myozyme – avalglucosidase alfa – is in line for a potential US approval by May next year after the US FDA agreed to a speedy review of the enzyme replacement therapy, unlike its European counterparts.
The French major stressed to Scrip that patients enrolled in its fitusiran clinical trials often have other health issues and various co-morbidities, so it is too early to know if the adverse events are treatment-related.