Medication Monitor

Generic Name (Trade Name—Company)
November 18, 2015

Antihemophilic factor (recombinant), polyethylene glycol

(Adynovate—Baxalta US Inc.)
Modified antihemophilic factor receives FDA approval for hemophilia A

FDA has approved antihemophilic factor (recombinant), polyethylene glycol (PEGylated), for use in adults and adolescents aged 12 years and older who have hemophilia A. The new therapy has been approved under the trade name Adynovate.

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.

Adynovate is approved for on-demand treatment and control of bleeding episodes and to reduce the frequency of bleeding episodes in patients with hemophilia A. Adynovate consists of the full-length coagulation Factor VIII molecule (historically known as antihemophilic factor) linked to other molecules, known as polyethylene glycol (PEGylated). This link makes the product last longer in the patient’s blood.

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 treatment regimen to on-demand therapy. The trial demonstrated that Adynovate was effective in reducing the number of bleeding episodes during routine care. In addition, Adynovate was effective in treating and controlling bleeding episodes. No safety concerns were identified during the trial.