Canada is the first country to approve Kovaltry™ a new full-length Antihemophilic Factor (Recombinant) for adults and children with hemophilia A1
TORONTO, Feb. 3, 2016 /CNW/ - Bayer announced today that Health Canada approved Kovaltry™ Antihemophilic Factor (Recombinant) for use in adults and children with hemophilia A for routine prophylactic treatment to prevent or reduce the frequency of bleeding episodes, control and prevention of episodic bleeding, and peri-operative management (surgical prophylaxis).1
Canada is the first country to receive regulatory approval of Kovaltry. Kovaltry is Bayer's third generation recombinant FVIII product, similar to Kogenate FS and manufactured using advanced technologies.
"The approval of Kovaltry as a successor to Kogenate FS is a milestone for the hemophilia community in Canada. We welcome the enhanced characteristics that Kovaltry brings to factor VIII replacement therapy. Because of variability in patient responses and in patient preferences, new treatment options like Kovaltry are important to ensure optimal management of hemophilia A," says Dr. Jerry Teitel, MD, FRCPC, Department of Medicine, University of Toronto, and Director of the Hemophilia Treatment Centre at St. Michael's Hospital. "Product choice and flexible dosing, based on individualized patient needs, provides our community with greater opportunities for positive outcomes."
Kovaltry contains the same amino acid sequence as Kogenate FS. It is very similar to the Factor VIII that occurs naturally in human blood. In patients with hemophilia A, who do not have enough natural Factor VIII in their blood, Kovaltry provides additional Factor VIII to help prevent and/or control bleeding.1 Kovaltry is given directly into the blood through an injection in a vein.1
The extensive LEOPOLD program (Long-Term Efficacy Open-Label Program in Severe Hemophilia A Disease) evaluated safety, efficacy and pharmacokinetics of Kovaltry in three open-label, multicentre clinical trials. A total of 204 male previously treated patients (PTPs) with severe hemophilia A (≤ 1% FVIII activity) have been included in the trial program.1 There were 153 subjects aged ≥ 12 years old, and 120 of them had ≥ 50 exposure days (EDs) in the clinical trial.1 There were 51 subjects aged < 12 years old, and 50 of them had ≥ 50 EDs in the clinical trial.
The recommended adult dose for routine prophylaxis is 20 to 40 IU of Kovaltry per kg of body weight two or three times per week.1 In children ≤ 12 years old, the recommended dose for routine prophylaxis is 20 to 50 IU of Kovaltry per kg body weight twice weekly, three times weekly, or every other day according to individual requirements.1 Kovaltry is administered using the Vial Adapter reconstitution set.
"Bayer has a long and positive history with the hemophilia community and continues to be dedicated to the area to provide innovative and effective new treatment options that improve the lives of Canadian patients," says Alok Kanti, President and CEO, Bayer. "The Kovaltry approval is another great step forward and an example of Bayer's corporate mission of Science For A Better Life."
About Hemophilia A
Hemophilia A, also known as factor VIII deficiency or classic hemophilia is a largely inherited bleeding disorder in which one of the proteins needed to form blood clots in the body is missing or reduced. Hemophilia A, the most common type of hemophilia, is caused by deficient or defective blood coagulation proteins, known as Factor VIII. Hemophilia A is characterized by prolonged or spontaneous bleeding, especially into the muscles, joints or internal organs.
About Hematology at Bayer
Bayer is committed to delivering Science For A Better Life by advancing a portfolio of innovative treatments. Hematology at Bayer includes an approved treatment for hemophilia A and numerous compounds in various stages of development for hemophilia, sickle cell anemia, and other blood and bleeding disorders. Together, these compounds reflect the company's commitment to research and development for these indications, prioritizing specific targets for intervention with the potential to improve the way that rare blood and bleeding disorders are treated.
Bayer: Science For A Better Life
Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At the same time, the Group aims to create value through innovation, growth and high earning power. Bayer is committed to the principles of sustainable development and to its social and ethical responsibilities as a corporate citizen. In fiscal 2014, the Group employed around 119,000 people and had sales of EUR 42.2 billion. Capital expenditures amounted to EUR 2.5 billion, R&D expenses to EUR 3.6 billion. These figures include those for the high-tech polymers business, which was floated on the stock market as an independent company named Covestro on October 6, 2015.
In Canada, Bayer had sales of $1.8 million CAD in 2015 and 1,500 employees at year-end.
For more information, go to www.bayer.com.
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1 Kovaltry Canadian Product Monograph
Shah A, Delesen H, Garger S, Lalezari S. Pharmacokinetic properties of BAY 81-8973, a new full-length recombinant Factor VIII product Haemophilia. 2014.
Kavakli K, Yang R, Rusen L, Beckmann H, Tseneklidou-Stoeter D, Maas Enriquez M. Prophylaxis Versus On-Demand Treatment With BAY 81-8973, a Full-Length Plasma-Protein-Free rFVIII Product: Results From a Randomized Trial (LEOPOLD II). J Thromb Haemost. 2014 Dec 24.
Ljung R, Kenet G, Mancuso M, Kaleva V, Rusen L, Tseneklidou-Stoeter D, et al. BAY 81-8973 safety and efficacy for prophylaxis and treatment of bleeds in previously treated children with severe haemophilia A: results of the LEOPOLD Kids Trial. Haemophilia. 2015 Dec 9.
SOURCE Bayer Inc.
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