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FDA Approves Additional Vial Sizes for Nuwiq®

September 5, 2017

The U.S. Food and Drug Administration has approved additional vial sizes for Nuwiq®, Octapharma’s recombinant FVIII therapy to treat hemophilia A patients. The new vial sizes will include 2500, 3000 and 4000 International Units (IU) and will be available in September 2017. The existing sizes include 250, 500, 1000 and 2000 IU.

Nuwiq® is indicated for on-demand treatment and control of bleeding episodes, routine prophylaxis to reduce the frequency of bleeding episodes and perioperative management of bleeding. Nuwiq® is the first B-domain-deleted recombinant FVIII derived from a human cell line. The product is cultured without using additives of human or animal origin, and is not chemically modified or fused with another protein.

The larger vial stengths were added to provide more options for dosing and to aid clinicians in employing a personalized approach to treatment of hemophilia A patients, including pharmacokinetic (PK)-guided prophylaxis.

“The new vial options will benefit patients, physicians and healthcare professionals by providing greater treatment flexibility and convenience,” said Octapharma USA President Flemming Nielsen. “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.”

Source: Octapharma news release dated August 23, 2017