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news.The European Medicines Agency (EMA) has accepted the filing of the Marketing Authorization Application (MAA) by Inspiration Biopharmaceuticals for IB1001 used to treat hemophilia B.
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IB1001 is a recombinant factor IX (FIX) product, which helps prevent bleeding in individuals with hemophilia B.
The MAA comprises the data from the clinical program for IB1001, which was conducted by Inspiration in the US, Europe, Israel and India, to test its efficacy.
Inspiration and its partner Ipsen intend to develop and commercialize a range of hemophilia products, including Inspiration inlicensing OBI-1 from Ipsen, as well as Ipsen providing Inspiration with funding.
Ipsen chairman and CEO said the filing of IB1001 with the EMA is a crucial step in the development of their hemophilia franchise.