Baxalta: Adynovate Meets Endpoints In Phase 3 Study Of Hemophilia A Patients

(RTTNews) - Biopharmaceutical company Baxalta Inc. (BXLT) announced initial results from a Phase 3 clinical trial of Adynovate or Antihemophilic Factor (Recombinant), PEGylated, an extended circulating half-life recombinant Factor VIII treatment for hemophilia A based on Advate, or Antihemophilic Factor (Recombinant).

Adynovate met its primary endpoint in the uncontrolled, open-label, multi-center Phase 3 study, as no patients developed inhibitory antibodies to Adynovate. In addition, no treatment-related serious adverse events were reported. Nearly 73 percent of patients had no joint bleeds while on treatment with Adynovate, and nearly 40 percent experienced zero bleeds.

The study enrolled 73 previously-treated patients or PTPs with severe hemophilia A, younger than 12 years of age, and assessed the treatment's hemostatic efficacy in prophylaxis and treatment of bleeding episodes.

Adynovate was approved by the U.S. Food and Drug Administration or FDA in November 2015 for use in adolescent and adult hemophilia patients, 12 years and older, for on-demand treatment and control of bleeding, and prophylaxis to reduce the frequency of bleeding episodes.

Baxalta said that with the study results, it plans to file for marketing authorization in Europe and aims to file for a pediatric indication in the U.S. in early 2016. Adynovate is currently under regulatory review in Japan, Canada and Switzerland. Baxalta plans to present the complete data from this study at a congress in 2016.