March 29, 2016
Bayer Receives Approval for Kovaltry® for the Treatment of Hemophilia A in Japan
Health, Labour and Welfare (MHLW) in Japan for Kovaltry®, a full-length
unmodified, recombinant factor VIII product for the treatment of hemophilia A.
The approval is based on results from the LEOPOLD clinical trials, which
demonstrated that Kovaltry controls and prevents bleeding in children,
adolescents and adults with hemophilia A.
"The approval of Kovaltry in Japan is an important example of Bayer's
long-standing and continued commitment to the Hemophilia community," said Dr.
Joerg Moeller, member of the Executive Committee of Bayer AG's Pharmaceutical
Division and Head of Development. "We are proud that Kovaltry, which
demonstrated efficacy as a two or three-times per week prophylactic treatment,
will provide flexibility to tailor the treatment to the specific needs of
people living with hemophilia A."
Kovaltry is already approved in Canada, the US, and the EU. Bayer is pursuing
regulatory approvals of Kovaltry for the treatment of hemophilia A in further
markets across the world.
The approval of Kovaltry builds upon Bayer's growing hematology portfolio which
also includes Kogenate® Bayer, a product currently on the market in more than
70 countries globally, 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 D
isease) 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 and 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 about 5,000 in Japan. Over
time, hemophilia A can cause prolonged or spontaneous bleeding, especially into
the joints, muscles or internal organs.
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