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Octapharma Announces FDA Approval of NUWIQ New Strengths, Expanding Hemophilia A Treatment Options


HOBOKEN, N.J. (August 22, 2017) - Octapharma USA today announced the U.S. Food and Drug Administration (FDA) has approved new product strengths for NUWIQ®, offering added convenience by potentially reducing the number of vials needed for Hemophilia A patients.

The agency approved new single dose NUWIQ® vial strengths of 2500, 3000 and 4000 International Units (IU), which will be available for ordering in the U.S. starting September 2017. These new vial strengths will be provided in addition to the already available strengths of 250, 500, 1000 or 2000 IU. NUWIQ® is the only recombinant Factor VIII (FVIII) providing patients a wide array of vials with the lowest diluent volume of 2.5ml.

NUWIQ® Antihemophilic Factor (Recombinant) Lyophilized Powder for Solution for Intravenous Injection is a recombinant antihemophilic 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 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."

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. 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 (PK)-guided personalized prophylaxis approach - wherein the dosing is further optimized compared to standard prophylaxis.

During the recent International Society on Thrombosis and Haemostasis (ISTH) Congress, results of Octapharma's clinical trial on the PK-guided dosing with NUWIQ® were presented. In the GENA-21 (NuPreviq) study, adult Hemophilia A patients were originally started on infusions three times per week or every other day. Subsequent dosing intervals were then determined based on individual PK data. The investigators observed that 83% of participants were spontaneous bleed-free throughout the six-month study period, and 57% of patients were able to decrease infusions to twice-weekly or less.1 Octapharma's ongoing clinical trial GENA-21b is designed to confirm the results of GENA-21.

NUWIQ® Important Safety Information

NUWIQ® is contraindicated in patients who have manifested life-threatening immediate hypersensitivity reactions, including anaphylaxis, to the product or its components. Hypersensitivity reactions, including anaphylaxis, are possible. Should symptoms occur, discontinue NUWIQ® and administer appropriate treatment. Development of Factor VIII neutralizing antibodies (inhibitors) may occur. If expected plasma Factor VIII activity levels are not attained, or if bleeding is not controlled with an appropriate dose, perform an assay that measures Factor VIII inhibitor concentration. Monitor all patients for Factor VIII activity and development of Factor VIII inhibitor antibodies. The most frequently occurring adverse reactions (0.7%) in clinical trials were paresthesia, headache, injection site inflammation, injection site pain, non-neutralizing anti-Factor VIII antibody formation, back pain, vertigo, and dry mouth. For full prescribing information on NUWIQ®, please visit www.nuwiqusa.com.

About the Octapharma Group

Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein products manufacturers in the world and has been committed to patient care and medical innovation since 1983. Its core business is the development and production of human proteins from human plasma and human cell lines. Octapharma employs approximately 7,100 people worldwide to support the treatment of patients in over 113 countries with products across the following therapeutic areas: Hematology (coagulation disorders), Immunotherapy (immune disorders) and Critical Care. The company's American subsidiary, Octapharma USA, is located in Hoboken, N.J. Octapharma operates two state-of-the-art production sites licensed by the U.S. Food and Drug Administration (FDA), providing a high level of production flexibility. For more information, please visit www.octapharmausa.com.

REFERENCES

1 - Octapharma, Data on file. 2015.

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