baxalta

Baxalta seeks European marketing rights for haemophilia drug

pharmafile | March 3, 2016 | News story | Research and Development, Sales and Marketing |  Adynovi haemophilia a, Baxalta 

Baxalta says it has filed for marketing authorisation for its haemophilia drug Adynovi with European regulators.

The European Medicines Agency (EMA) filing is based on data from three Phase III trials, announced in December. The drug was studied for the perioperative control of haemostasis among patients with severe haemophilia A undergoing surgical procedures.

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

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Haemophilia A is a challenging chronic disease; treatment regimens require regular infusions to reduce the risk of bleeding. Haemophilia A affects more than 400,000 people globally and an estimated 75% of people the condition are inadequately treated.

The US FDA approved the drug last November for use in the American market, where it is marketed as Adynovate. 

Anjali Shukla

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