Baxalta Incorporated, a global biopharmaceutical company, announced the launch and first shipments of Adynovate [Antihemophilic Factor (Recombinant), PEGylated], an extended circulating half-life recombinant factor VIII (rFVIII) treatment for haemophilia A based on full-length Advate [Antihemophilic Factor (Recombinant)]. The treatment was approved by the US Food and Drug Administration (FDA) in November.
“Patients living with haemophilia are increasingly looking for and need treatment options that can address their individual needs,” said Dr. Michael Tarantino, medical director of the Bleeding & Clotting Disorders Institute. “The simplicity of Adynovate’s twice weekly dosing schedule offers an important new option for the haemophilia community, delivering first and foremost on what matters most - bleed protection, while also easing the schedule of their prophylactic treatment.”
With Adynovate, Baxalta expands its industry-leading haemophilia portfolio and further widens the variety of treatment options to meet individual patient needs at each treatment stage. The company continues to invest in Adynovate to expand the product’s value for more haemophilia patients worldwide. As the company prepares for additional global introductions of Adynovate, the treatment has been submitted for regulatory approval in Japan. Following completion of the paediatric study in early 2016, Baxalta expects to file for marketing authorisation in Europe.
“We are excited to be able to introduce Adynovate to patients in the United States just weeks after receiving FDA approval, marking the first of many planned product launches in our broad pipeline,” said Brian Goff, executive vice president and president, Hematology. “Looking ahead, we’re continuing to build the value of Adynovate with additional studies for new indications, and plan to deliver this innovative treatment to more patients around the world as we continue to pursue our vision of a bleed-free world."
Adynovate was developed through a collaboration with Nektar Therapeutics. Adynovate, Antihemophilic Factor (Recombinant), PEGylated, is a human antihemophilic factor indicated in adolescent and adult patients (12 years and older) with haemophilia A (congenital factor VIII deficiency) for on-demand treatment and control of bleeding episodes, routine prophylaxis to reduce the frequency of bleeding episodes.
Adynovate is not indicated for the treatment of von Willebrand disease.