Sanofi Nabs Priority Review For New Pompe Drug
And Rilzabritib Gets US Fast Track For ITP
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.
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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.
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.
Sanofi is paying for $3.68bn cash for Principia to get the US biotech’s drug development platform and nascent pipeline, including a brain-penetrant BTK inhibitor in Phase III for multiple sclerosis.