FDA Approves ENBREL as First Therapy to Inhibit Bone and Joint Damage In Psoriatic Arthritis Patients
August 26, 2003
THOUSAND OAKS, Calif. and COLLEGEVILLE, Pa., Aug. 25 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has approved an expanded indication for ENBREL(R) (etanercept) to inhibit the progression of structural damage of active arthritis in patients with psoriatic arthritis. The approval is being announced today by Amgen (Nasdaq: AMGN) and Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE).
ENBREL is the first and only approved therapy for both the inhibition of structural damage and the reduction in signs and symptoms of patients with psoriatic arthritis.
"This is the first time a large clinical trial has demonstrated inhibition of radiographic progression of joint damage in people with psoriatic arthritis," says Willard Dere, M.D., Vice President of Clinical Development for Amgen. "These data underscore the benefits of treating psoriatic arthritis patients with ENBREL."
Approval was based on a phase 3 study evaluating 205 patients with active psoriatic arthritis. ENBREL demonstrated inhibition of joint damage over a one-year study period, while x-rays of patients receiving a placebo showed progressive joint destruction.
"ENBREL has now been shown to inhibit underlying joint damage in two
distinct diseases, rheumatoid arthritis, and now, psoriatic arthritis", says Victoria Kusiak, M.D., Vice President of Global Medical Affairs and North American Medical Director of Wyeth Pharmaceuticals. "As with rheumatoid arthritis, treatment with ENBREL can improve the painful and debilitating symptoms of psoriatic arthritis. "
Adverse events were similar to those reported in previous clinical trials of ENBREL in patients with rheumatoid arthritis. There was no increase in the number of serious adverse events occurring in patients treated with ENBREL compared to those receiving placebo. Only the rate of injection site reactions (ISRs) in patients receiving ENBREL was statistically different compared to those receiving placebo (36 percent with ENBREL versus 9 percent in placebo-treated patients).
ABOUT PSORIATIC ARTHRITIS
Psoriatic arthritis is a chronic inflammatory disease of the joints and connective tissue. The disease combines joint pain and swelling that can lead to crippling debilitation with inflamed and irritated scaly red patches of skin on the body. The disease can be difficult to diagnose, particularly in its milder forms and earlier stages. Up to one million people in the U.S. population have psoriatic arthritis.
ENBREL is the only fully human anti-TNF receptor approved to reduce signs and symptoms, improve physical function, and inhibit 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 in patients with active psoriatic arthritis. ENBREL is the only biologic therapy approved for first-line treatment of RA patients, and can be used in combination with methotrexate or alone. 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 disease-modifying medicines. It is also the first biologic approved to treat the signs and symptoms in patients with active ankylosing spondylitis (AS).
The benefits and long-term tolerability profile of ENBREL have been
established in the treatment of over 180,000 patients worldwide across all indications.
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 psoriatic arthritis, RA and AS. The binding of ENBREL to TNF renders the bound TNF biologically inactive, resulting in significant reduction in inflammatory activity.
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
* 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 adults.
-- 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 http://www.enbrel.com or by calling toll free 888-4ENBREL (888-436-2735).
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