Baxalta files for EU approval of haemophilia A drug Adynovi

Baxalta has submitted a marketing authorisation application to the European Medicines Agency for a new treatment for haemophilia A.

Adynovi is an extended circulating half-life recombinant Factor VIII (rFVIII) treatment designed for paediatric, adolescent and adult patients with hemophilia A and for use during surgery. It is currently licensed in the US under the name Adynovate.

It is the only rFVIII treatment for haemophilia A developed based on the demonstrated efficacy of Advate, the world's most prescribed FVIII treatment, with more than 12 years of patient experience worldwide.

The new drug has been studied in patients between the ages of 12 to 65 across three phase III clinical trials, during which it demonstrated its safety and efficacy.

Brian Goff, executive vice-president and president of haematology at Baxalta, said: "As we build on our market-leading portfolio of direct factor replacement treatments, we continually bring new options to haemophilia patients."

Adynovi is also currently under regulatory review in Japan, Canada and Switzerland.