FDA Approves ENBREL for Once-Weekly Dosing
- New Dosing Option Offers Convenience to Patients While Providing
Comparable Efficacy and Tolerability -
THOUSAND OAKS, Calif. and COLLEGEVILLE, Pa., Oct. 20 --
Amgen (Nasdaq: AMGN) and Wyeth Pharmaceuticals, a division of Wyeth
(NYSE: WYE) today announced that the U.S. Food and Drug Administration (FDA)
has approved a 50 mg once-weekly dosage of Enbrel(R) (etanercept) for adult
patients across all indications, including moderately-to-severely active
rheumatoid arthritis (RA), active arthritis in patients with psoriatic
arthritis and active ankylosing spondylitis (AS), and a 0.8mg/kg once-weekly
dosage (maximum 50 mg per week) for patients ages four to 17 years with
moderately-to-severely active juvenile rheumatoid arthritis. Instead of
taking two 25 mg injections three to four days apart, patients can now take
both injections on the same day.
"Patients receiving ENBREL can benefit from the long-term efficacy and
tolerability profiles of ENBREL while also now enjoying the convenience of
once-weekly dosing," said Dr. Willard Dere, vice president of clinical
development for Amgen.
Data supporting the efficacy and tolerability of the ENBREL once-weekly
dosage are from a Phase 3 double-blind, placebo-controlled study of
420 patients with active RA. In a 16-week study, patients either were treated
with ENBREL 50 mg once weekly (administered in two 25 mg injections), ENBREL
25 mg twice weekly, or placebo for eight weeks followed by ENBREL 25 mg twice
weekly for the remaining eight weeks.
After eight (the primary endpoint) and 16 weeks, there were no significant
differences in ACR 20 response scores (a 20 percent improvement in signs and
symptoms) between the two ENBREL groups. The tolerability profile for
once-weekly dosing was comparable to that of twice-weekly dosing.
"This approval allows rheumatologists and dermatologists to provide their
patients with more convenient dosing," said Victoria Kusiak, M.D., vice
president of global medical affairs and North American medical director of
Wyeth Pharmaceuticals. "And, of course, doctors can feel confident that the
new once-weekly dosing provides comparable efficacy and tolerability to
twice-weekly dosing of ENBREL."
Adverse events were similar to those reported in previous clinical trials
of ENBREL, with injection site reactions occurring more frequently than in the
ENBREL is the only fully human TNF receptor approved to reduce signs and
symptoms, improve physical function, and inhibit the progression of structural
damage in patients with moderately to severely active rheumatoid arthritis
(RA), and to reduce the signs and symptoms and inhibit the progression of
structural damage of active arthritis in patients with psoriatic arthritis.
ENBREL is the only biologic therapy approved for first-line treatment of RA
patients, and can be used alone or in combination with methotrexate. It is
approved to reduce the signs and symptoms of moderately to severely active
polyarticular-course juvenile rheumatoid arthritis (JRA) in patients who have
had an inadequate response to one or more disease-modifying antirheumatic
drugs (DMARDs). It is also the first biologic approved to treat the signs and
symptoms in patients with active ankylosing spondylitis (AS).
ENBREL has been used by more than 200,000 patients worldwide across
indications since becoming commercially available nearly five years ago.
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 that causes the inflammatory process of RA, JRA,
psoriatic arthritis and AS. The binding of ENBREL to TNF renders the bound
TNF biologically inactive, resulting in significant reduction in inflammatory
Since the product was first introduced, the following have been reported
in patients using ENBREL:
* Serious Infections
- Many occurred in people prone to infection, such as those with
advanced or poorly controlled diabetes
- Some serious infections were fatal
- Rare cases of tuberculosis
* What to do / Not do
- Do not start ENBREL if you have an infection or are allergic to
ENBREL or its components
- Tell your doctor if you are prone to infection
- Stop ENBREL if a serious infection occurs
- Contact your doctor if you have questions about ENBREL or develop
* Serious nervous system disorders such as multiple sclerosis, seizures,
or inflammation of the nerves of the eyes.
- Tell your doctor if you have ever had any of these disorders or if
you develop them after starting ENBREL
* Rare reports of serious blood disorders (some fatal)
- Contact your doctor immediately if you develop symptoms such as
persistent fever, bruising, bleeding, or paleness
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 cancer has not increased with extended exposure to
ENBREL and is similar to the expected rate.
* ENBREL can also cause injection site reactions.
* In a medical study of patients with JRA, infections, headaches,
abdominal pain, vomiting, and nausea occurred more frequently than in
- The kinds of infections reported were generally mild and similar to
those usually seen in children
- Other serious adverse reactions were reported rarely, including
serious infections (two percent) and depression/personality
disorder (one percent)
Amgen and Wyeth Pharmaceuticals, a division of Wyeth, market ENBREL in
North America. Wyeth markets ENBREL outside of North America. Immunex
Corporation, a wholly owned subsidiary of Amgen, manufactures ENBREL.
Additional information about ENBREL, including full Prescribing Information,
can be found on the Web site sponsored by the companies at www.enbrel.com or
by calling toll free 888-4ENBREL (888-436-2735).
Amgen is a global biotechnology company that discovers, develops,
manufactures and markets important human therapeutics based on advances in
cellular and molecular biology.
Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the
areas of women's health care, cardiovascular disease, central nervous system,
inflammation, hemophilia, oncology and vaccines. Wyeth is one of the world's
largest research-driven pharmaceutical and health care products companies. It
is a leader in the discovery, development, manufacturing, and marketing of
pharmaceuticals, vaccines, biotechnology products and non-prescription
medicines that improve the quality of life for people worldwide. The
Company's major divisions include Wyeth Pharmaceuticals, Wyeth Consumer
Healthcare and Fort Dodge Animal Health.
This news release contains forward-looking statements that involve
significant risks and uncertainties, including those discussed below and
others that can be found in Amgen's Form 10-K for the year ended December 31,
2002, and in Amgen's periodic reports on Form 10-Q and Form 8-K. Amgen is
providing this information as of the date of this news release and does not
undertake any obligation to update any forward-looking statements contained in
this document as a result of new information, future events or otherwise.
No forward-looking statement can be guaranteed and actual results may
differ materially from those we project. Amgen's results may be affected by
its ability to successfully market both new and existing products domestically
and internationally, sales growth of recently launched products, difficulties
or delays in manufacturing its products, and regulatory developments (domestic
or foreign) involving current and future products and manufacturing
In addition, sales of Amgen's products are affected by reimbursement
policies imposed by third party payors, including governments, private
insurance plans and managed care providers, and may be affected by domestic
and international trends toward managed care and healthcare cost containment
as well as possible U.S. legislation affecting pharmaceutical pricing and
reimbursement. Government regulations and reimbursement policies may affect
the development, usage and pricing of Amgen's products. Furthermore, Amgen's
research, testing, pricing, marketing and other operations are subject to
extensive regulation by domestic and foreign government regulatory
authorities. Amgen or others could identify side effects or manufacturing
problems with its products after they are on the market. In addition, Amgen
competes with other companies with respect to some of its marketed products as
well as for the discovery and development of new products. Discovery or
identification of new product candidates cannot be guaranteed and movement
from concept to product is uncertain; consequently, there can be no guarantee
that any particular product candidate will be successful and become a
In addition, while Amgen routinely obtains patents for its products and
technology, the protection offered by its patents and patent applications may
be challenged, invalidated or circumvented by its competitors. Further, some
raw materials, medical devices and component parts for Amgen's products are
supplied by sole third party suppliers.
The statements in this press release that are not historical facts are
forward-looking statements based on current expectations of future events that
involve risks and uncertainties including, without limitation, risks
associated with the inherent uncertainty of pharmaceutical research, product
development, manufacturing, and commercialization, and economic conditions,
including interest and currency exchange rate fluctuations, the impact of
competitive or generic products, product liability and other types of
lawsuits, the impact of legislative and regulatory compliance and obtaining
approvals, and patents, and other risks and uncertainties, including those
detailed from time to time in Wyeth's periodic reports, including quarterly
reports on Form 10-Q and the Annual Report on Form 10-K, filed with the
Securities and Exchange Commission. Actual results may vary materially from
the forward-looking statements.
Wyeth assumes no obligation to publicly update any forward-looking
statements, whether as a result of new information, future events or
CONTACT: Media, Andrea Rothschild, +1-805-447-6287, or Investors, Cary
Rosansky, +1-805-447-1060, both of Amgen; or Media, Douglas Petkus,
+1-484-865-5140, or Investors, Justin Victoria, +1-973-660-5340, both of Wyeth
Web site: http://www.enbrel.com
Web site: http://www.amgen.com