The U.S. Food and Drug Administration approved Baxalta Inc's drug Adynovate, to control and reduce the frequency of bleeding episodes in patients with Hemophilia A, a type of rare bleeding disorder.
Adynovate is modified to last longer in the blood and potentially require less frequent injections than unmodified Antihemophilic Factor when used to reduce the frequency of bleeding.
‘The approval of Adynovate provides an important therapeutic option for use in the care of patients with Hemophilia A and reduces the frequency of Factor VIII infusions needed to avoid bleeding. Adynovate is manufactured by Baxalta US Inc., based in Westlake Village, California.’
Data from a late-stage study, which tested 137 patients, showed that Adynovate was effective in reducing and controlling bleeding episodes, compared with Advate. Baxalta, which also owns Advate, said the drug is the world's most prescribed hemophilia treatment.
"The approval of Adynovate provides an important therapeutic option for use in the care of patients with Hemophilia A and reduces the frequency of Factor VIII infusions needed to avoid bleeding," said Karen Midthun, M.D., director of the FDA's Center for Biologics Evaluation and Research.
The safety and efficacy of Adynovate were evaluated in a clinical trial of 137 adults and adolescents aged 12 years and older, which compared the recommended routine prophylactic (preventative) treatment regimen to on-demand therapy.
The trial demonstrated that Adynovate was effective in reducing the number of bleeding episodes during routine care. Additionally, Adynovate was effective in treating and controlling bleeding episodes. No safety concerns were identified during the trial.
Baxalta, spun off from Baxter International Inc earlier this year, developed Adynovate in partnership with Nektar Therapeutics Inc.