Baxalta files for approval of hemophilia drug Adynovi with EMA

3 March 2016

US biotech firm Baxalta (NYSE: BXLT) has submitted a Marketing Authorization Applicationto the European Medicines Agency for approval of Adynovi, an extended circulating half-life recombinant Factor VIII (rFVIII) treatment,for pediatric, adolescent and adult patients with hemophilia A and for use during surgery.

Currently licensed in the USA as Adynovate [Antihemophilic Factor (Recombinant), PEGylated] (The Pharma Letter November 14, 2015) and under regulatory review in Japan, Canada and Switzerland, Adynovi is the only rFVIII treatment for hemophilia A developed based on the demonstrated efficacy of Advate [Antihemophilic Factor (recombinant)].

''We are dedicated to bringing Adynovi to hemophilia A patients all over the world,'' said Brian Goff, executive vice president and president, Hematology, Baxalta,'' adding: “As we build on our market-leading portfolio of direct factor replacement treatments, we continually bring new options to hemophilia patients, empowering them to manage their hemophilia, with their caregivers, in the way that works best for them.''

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