March 17, 2016
Bayer Receives FDA Approval for Kovaltry® for the Treatment of Children and Adults with Hemophilia A
approved Bayer's Kovaltry® antihemophilic factor VIII (recombinant) for the
treatment of hemophilia A in children and adults. Kovaltry is an unmodified,
full-length recombinant factor VIII product. The approval is based on results
from the LEOPOLD clinical trials, which demonstrated that Kovaltry controls
bleeds, and reduces frequency of bleeding episodes with routine prophylaxis in
children and adults with hemophilia A when used two or three times per week.
"We are proud that, based on our comprehensive development program, physicians
can now consider twice weekly prophylactic treatment with Kovaltry among the
treatment options," said Dr. Joerg Moeller, member of the Executive Committee
of Bayer AG's Pharmaceutical Division and Head of Development. "At Bayer we
have been developing and producing treatments for hemophilia A for more than
Bayer recently received approval of Kovaltry in Europe and Canada. Bayer is
pursuing regulatory approvals of Kovaltry for the treatment of hemophilia A in
further markets across the world.
The approvals of Kovaltry build upon Bayer's growing hematology portfolio which
also includes Kogenate® Bayer, a product currently on the market in more than
70 countries, as well as a long-acting recombinant factor VIII pipeline
candidate. Bayer is also pursuing alternative treatment approaches in
preclinical and early clinical development, such as factor VIII gene therapy
and inhibition of tissue factor pathway inhibitor (TFPI) in hemophilia, as well
as in other blood disorders.
The LEOPOLD (Long-Term Efficacy Open-Label Program in Severe Hemophilia A
Disease) Clinical Development Program consists of three multinational clinical
trials designed to evaluate the pharmacokinetics, efficacy and safety of
Kovaltry in subjects with severe hemophilia A (<1% FVIII:C). The combined
trials evaluated Kovaltry in more than 200 children and adults with severe
hemophilia A from 60 sites in 25 countries worldwide.
Hemophilia affects approximately 400,000 people around the world and is a
largely inherited disorder in which one of the proteins needed to form blood
clots is missing or reduced. Hemophilia A is the most common type of hemophilia
where factor VIII is missing or reduced. Hemophilia A affects 1 in 10,000
males, including more than 30,000 in Europe, and 16,000 in the U.S. today. Over
time, hemophilia A can cause prolonged or spontaneous bleeding, especially into
the joints, muscles or internal organs.
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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 2015, the Group
employed around 117,000 people and had sales of EUR 46.3 billion. Capital
expenditures amounted to EUR 2.6 billion, R&D expenses to EUR 4.3 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. For more information, go to www.bayer.com.
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