Sanofi Hampered By Fitusiran Clinical Hold In Hemophilia
Reports Of Non-Fatal Thrombotic Events
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.
You may also be interested in...
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'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.
Dupixent is already is a big seller in severe asthma in adults and adolescents but Sanofi is looking to expand the label after presenting data showing that it is the only biologic in Phase III trial to have demonstrated improved lung function in children.