FDA Approves New, More Convenient Vial Strengths for Hemophilia A Therapy Nuwiq

The U.S. Food and Drug Administration has approved new vial strengths for Octopharma’s hemophilia A therapy Nuwiq, which means patients will need fewer vials per treatment session.

Octapharma USA said single-dose strengths of 2,500, 3,000 and 4,000 International Units will be available in the United States in September. The vials are already available in strengths of 250, 500, 1,000 and 2,000 IUs.

Nuwiq (simoctocog alfa) contains recombinant blood clotting protein Factor VIII, which is missing or defective in hemophilia A. The IV therapy can prevent bleeding episodes and treat those that occur. And it can help doctors manage bleeding from an operation.

Octapharma said Nuwiq is the only recombinant Factor VIII treatment offered in a vast array of vials.

“The new vial options will benefit patients, physicians and healthcare professionals by providing greater treatment flexibility and convenience,” Flemming Nielsen, the president of Octapharma USA, said in a press release. “The variety of vial options will be particularly beneficial to patients who previously may have needed more than one of the lower-strength vials.”

Besides decreasing the number of vials that patients need, the new sizes can help heavier patients reduce their usage to as low one vial per treatment session, the company said.

The new products will also increase dosing flexibility by giving physicians a wider range of vial combinations to administer a prescribed dose.

They are likely to be particularly beneficial to those using Nuwig to prevent bleeding episodes, Octaparma added.

The company presented the results of a Phase 3 GENA-21 clinical trial (NCT01863758) of Nuwig as a preventive therapy at the International Society on Thrombosis and Haemostasis Congress in Berlin, July 8-13.

In the trial, adults with hemophilia A initially received Nuwiq three times a week, or every other day. Subsequent dosing depended on patients’ response.

The results showed that 83 percent of subjects did not have a bleeding episode during the six-month trial. In addition, 57 percent were able to reduce their treatments to twice a week or less.

Octapharma is conducting another Phase 3 clinical trial, GENA-21b (NCT02256917), to confirm the findings of GENA-21.