Baxalta submits sBLAs to FDA for approval of ADYNOVATE

Baxalta Inc., a worldwide leader in pharmaceuticals committed to developing therapies to combat orphan diseases, recently announced the submission of supplemental Biologics License Applications (sBLAs) for the approval of ADYNOVATE by the U.S. Food and Drug Administration (FDA).

ADYNOVATE is designed to be used in surgery and for the treatment of children ages 12 and younger that have been diagnosed with hemophilia A.

ADYNOVATE was originally approved by the FDA in November of last year to treat both adult and adolescent patients with hemophilia to reduce bleeding episodes associated with prophylaxis. It is currently the only medicine with a prolonged circulating half-life recombinant Factor VIII (rFVIII) designed to treat hemophilia A.

Baxalta submitted the sBLAs for ADYNOVATE after successful results of a Phase 3 trial that assessed the safety and effectiveness of the drug. The data collected from the trial met its primary goals with none of the patients that took part developing inhibitory antibodies to the medication. There were also no side effects reported during the duration of the trial.

Baxalta is committed to further developing ADYNOVATE to help treat patients on a worldwide scale. The company is currently seeking approval for ADYNOVATE in Europe, Japan, Canada and Switzerland.