Baxalta Submits Marketing Application For Adynovi In Europe, Shares Tick Higher

Shares of Baxalta Inc BXLT were trading higher by nearly 1 percent Wednesday after the company announced it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for approval of its ADYNOVI.

Baxalta completed a study in patients aged 12 to 16 and its EMA filing is based on data from three Phase 3 clinical trials. ADYNOVI is already licensed in the U.S. as ADYNOVATE and under regulatory review in Japan, Canada and Switzerland.

''We are dedicated to bringing ADYNOVI to hemophilia A patients all over the world,'' said Brian Goff, executive vice president and president, Hematology, Baxalta. ''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.''