Octapharma gets FDA approval for new product strengths of NUWIQ

HOBOKEN, N.J. — Octapharma USA today announced that the U.S. Food and Drug Administration has approved new product strengths for NUWIQ. The move potentially reduces the number of vials needed for hemophilia A patients, the company said.

The agency approved new-single dose vial strengths of 2500-, 3000- and 4000-IU, which will be available for ordering in the United States starting Sept. 2017. These new vial strengths will be provided in addition to the already available strengths of 250-, 500-, 1000- and 2000 IU. NUWIQ is the only recombinant Factor VIII providing patients a wide array of vials with the lowest diluent volume of 2.5ml, the company added.

NUWIQ anti-hemophilic factor (recombinant) lyophilized powder for solution for intravenous injection is a recombinant anti-hemophilic factor indicated in adults and children with hemophilia A for on-demand treatment and control of bleeding episodes; perioperative management of bleeding; and routine prophylaxis to reduce the frequency of bleeding episodes.

“The new vial options will benefit patients, physicians and healthcare professionals by providing greater treatment flexibility and convenience,” said Flemming Nielsen, Octapharma USA president. “The variety of vial options will be particularly beneficial to patients who previously may have needed more than one of the lower-strength vials. The availability of the new vial strengths further illustrates Octapharma’s unwavering commitment to the Hemophilia A community.”

The additional vial strengths offer benefits beyond potentially reducing the number of vials used per patient. The new vial sizes may benefit heavier patients who could use fewer product vials and, in some cases, just one vial, according to the company. More NUWIQ vial options will increase dosing flexibility by allowing physicians to select various vial combinations to align closer to the prescribed dose. The new vial sizes could be particularly beneficial to patients treated with NUWIQ utilizing a pharmacokinetic-guided personalized prophylaxis approach — wherein the dosing is further optimized compared with standard prophylaxis.