October 17, 2017
Bayer submits its extended half-life Hemophilia A compound for marketing authorization in Japan
Pivotal studies with BAY94-9027 showed that bleed protection was achieved with extended dosing intervalsBerlin, October 17, 2017 - Bayer has submitted an application for marketing
authorization for its extended half-life site-specifically PEGylated
recombinant human Factor VIII (BAY94-9027, damoctocog alfa pegol) for the
treatment of Hemophilia A in Japan. The regulatory submission is essentially
based on the results from the PROTECT VIII trial. In that trial, BAY94-9027
showed protection from bleeds with dosing intervals when used prophylactically
once every seven days, once every five days, and twice per week. Based on these
data Bayer submitted BAY94-9027 for marketing authorization in this indication
in the United States and Europe earlier this year already.
"Hemophilia A, affects approximately 5,000 patients in Japan. These patients
are nowadays living longer and more fully lives thanks to Factor VIII
replacement therapies," said Dr. Joerg Moeller, member of the Executive
Committee of Bayer AG's Pharmaceutical Division and Head of Development.
"Besides minimizing the impact of this life-long disease, newer treatment
options can reduce treatment burden and allow patients to live more normal,
active lifestyles - thereby making a significant difference in their lives."
In the PROTECT VIII study, BAY94-9027 provided good protection from bleeds when
used prophylactically once every seven days, once every five days, and twice
per week. BAY94-9027 was also effective for control of bleeding during surgical
procedures, and treatment of all bleeds, with the vast majority of bleeding
events being resolved with one or two infusions.
The standard-of-care for hemophilia A is factor VIII replacement therapy, which
needs to be regularly infused into the patient's vein to maintain factor levels
high enough to prevent bleeding into joints, muscles or other organs. Due to
the short half-life of most currently marketed factor VIII products,
prophylaxis may require treatment as often as every other day or three times
per week. BAY94-9027 is engineered to prolong activity in the body while
preserving full coagulation activity through PEGylation, where a PEG
(Polyethylenglycol) molecule is attached to the factor VIII protein at a
specific site. PEGylation technology is utilized to prolong the time of drug
circulation in the blood.
About Hemophilia A
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. In Hemophilia A, the most common type of
hemophilia, blood clotting is impaired as a result of a lack or defect of
coagulation factor VIII (FVIII). Patients therefore repeatedly experience
bleeds in muscles, joints or other tissues, which can result in chronic joint
damage. External injuries, even if they are trivial, can have serious
consequences if not treated appropriately, as the blood clots more slowly than
in healthy individuals. Hemophilia A has an estimated frequency of 1 in
5,000~10,000 male live births, affecting approximately 5,000 in Japan, 30,000
in Europe, and 14,000 in the U.S. today.
Hemophilia treatment has advanced considerably over the past decades with life
expectancy for people with hemophilia significantly increasing from about 11.4
years in 1920 to a potentially normal life span today. Today's research aims to
reduce burden of treatment and improve the quality of life of people with
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