Wyeth KK and Takeda Pharmaceutical Company
Limited ("Takeda") announced today that ENBREL (etanercept) will be launched in Japan for
the treatment of rheumatoid arthritis (RA) on March 30 under the co-promotion
agreement of both parties. The launch follows regulatory approval in January and
National Health Insurance (NHI) listing on March 18.
ENBREL is the only fully human, anti-TNF receptor approved to reduce the signs
and symptoms of RA in patients who had an inadequate response to existing
disease-modifying antirheumatic medicines. The biological product can be used alone
as a monotherapy and is administered twice weekly as a subcutaneous injection.
Initially the product will be made available to medical institutions participating
in an all-patient surveillance program.
"The results of the clinical studies with ENBREL in Japan were very
encouraging, with some patients responding as early as two weeks after beginning
treatment and reaching maximum relief within the first two months," said the primary
investigator Prof. Nobuyuki Miyasaka, M.D., Department of Bioregulatory Medicine and
Rheumatology of Tokyo Medical and Dental University.
"The launch of this therapeutic breakthrough brings physicians and patients a
new option in the treatment of rheumatoid arthritis. We look forward to providing
ENBREL to patients who have gone for so long with few effective options to
significantly reduce the painful symptoms of their disease," says Dr. Michio Suzukawa,
Corporate Officer, Director, Medical Affairs Division of Wyeth K. K.
"We are pleased to introduce ENBREL, which already has been widely used for RA
patients worldwide, with Wyeth K.K. in Japan," says Mr. Makoto Yamaoka, Managing
Director, General Manager of Pharmaceutical Marketing Division of Takeda.
About Rheumatoid Arthritis
Rheumatoid arthritis is a systemic, chronic and potentially disabling disorder that
affects about 700,000 people in Japan. The serious rheumatic disease causes the body's
immune system to attack the lining of the joints, resulting in pain and swelling and may
lead to fatigue, disability, deformity, organ damage, or premature death if not managed
effectively. In RA, the immune system attacks the body?fs own healthy cells, mistaking
them for cells that do not belong. This causes inflammation in the lining and connective
tissues of the joints. Generally, in Japan the disease affects about four times as many
women as men*. RA can develop at all ages including childhood; in most cases it develops
between the ages of 25 and 50.
* The Japan Medical Association
About ENBREL
In Japan ENBREL was approved for the treatment of rheumatoid arthritis in patients who
had an inadequate response to existing therapies. ENBREL acts by binding TNF, one of
the dominant inflammatory cytokines or regulatory proteins that play an important role
in both normal immune function and the cascade of reactions causing the inflammatory
process of rheumatoid arthritis. The binding of ENBREL to TNF renders the bound TNF
biologically inactive, resulting in significant reduction in inflammatory activity.
Additionally, ENBREL binds to lymphotoxin (LT)-alpha, another cytokine involved in the
inflammatory process of RA.
Globally physicians have become familiar with the benefits and proven long-term profile
of ENBREL. As of today, the product has been approved in more than 70 countries around
the world, and has been used to treat more than 280,000 patients worldwide across various
indications.
Important Treatment Considerations
Since the product was first introduced globally, serious infections, some involving
death, have been reported in patients using ENBREL. The product should be used with
caution in patients prone to infection. There have been reports of serious nervous-system
disorders such as multiple sclerosis, or inflammation of the nerves of the eyes. There
also have been rare reports of serious blood disorders, some involving death. It is
unclear if ENBREL has caused these nervous-system or blood disorders. The most frequent
adverse events in clinical trials in patients with rheumatoid arthritis (RA) were
infections, injection-site reactions, headaches, and respiratory disorders. In medical
studies of all TNF-inhibitors, a higher rate of lymphoma (a type of cancer) was seen
compared to the general population, however, the risk of lymphoma may be up to several
fold higher in RA patients. The role of TNF-inhibitors in the development of lymphoma
is unknown. The incidence of other cancers has not increased with extended exposure to
ENBREL and is similar to the expected rate.
About Wyeth K.K.
Wyeth K.K. is engaged in a full range of pharmaceutical business activities including
developing, importing, manufacturing and marketing pharmaceutical products with the
aim of becoming a leading company in the pharmaceutical industry in Japan. Our corporate
vision is Leading the way to a healthier world. We strive to achieve this vision by
bringing to the world pharmaceutical and health-care products that improve peoples'
lives and deliver outstanding value to our customers. Wyeth K.K. (WKK), previously known
as Wyeth Lederle Japan, Ltd., was established in 1998 with the combination of Lederle
Japan, Ltd. and Wyeth (Japan) Corporation, both of which were founded in the mid-1950's.
WKK's major shareholders are Wyeth with 60 percent of the equity and Takeda Pharmaceutical
Company Limited with 40 percent. Headquartered in Tokyo, WKK has more than 1,200 employees
with manufacturing facilities located in the city of Shiki, Saitama Prefecture and business
offices located in seven major cities throughout Japan. See details, at wyeth.jp.
About Takeda
Takeda, in its management plan, sets a course by which the company will become an
" R&D-driven world-class pharmaceutical company" . Takeda will exert its best efforts to
enhance its R&D pipeline in selected core therapeutic classes such as "lifestyle-related
diseases", "cancer and urological diseases and gynecological disorders", "central nervous
system disorders, and bone and joint diseases", and "life-cycle management of drugs for
digestive system disorders".
Takeda is reinforcing its in-house R&D, promoting life cycle management, and actively
introducing new products and form alliances in order to realize its management mission of
?estriving toward better health for individuals and progress in medicine by developing
superior pharmaceutical products'. See details at takeda.co.jp.
View drug information on Enbrel.
Комментариев нет:
Отправить комментарий