FDA Approves Longer Lasting New Treatment for Hemophilia A

Modified version of Adynovate lasts longer in the blood for less frequent injections.

The FDA today gave the thumbs up to a new therapeutic option for patients with hemophilia.

Adynovate [Antihemophilic Factor (Recombinant) PEGylated] was approved for adults and adolescents age 12 years and older with hemophilia A.

The modified version of Adynovate lasts longer in the blood, which could lead to less frequent injections than with unmodified antihemophilic factor to reduce bleeding frequency.

“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,” Karen Midthun, MD, director of the FDA Center for Biologics Evaluation and Research, said in a press release.

The drug was approved for the on-demand treatment and control of bleeding episodes and to decrease the frequency of bleeding episodes in hemophilia A patients.

Adynovate is comprised of the full-length coagulation factor VIII molecule (antihemophilic factor) associated with polyethylene glycol (PEGylated) molecules, which allows the drug to last longer.

The approval of Adynovate followed a clinical trial enrolling 137 adults and adolescents 12 years of age and older.

The trial compared the recommended routine preventative therapeutic regimen with on-demand therapy, which demonstrated the efficacy of Adynovate in decreasing the frequency of bleeding episodes during routine care.

Furthermore, Adynovate showed efficacy in the treatment and control of bleeding episodes. There were no safety concerns found during the trial.