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|Amgen Submits Data To FDA Supporting Once-Weekly Dosing Of Enbrel|
|FOR IMMEDIATE RELEASE|
THOUSAND OAKS, Calif., Dec. 23, 2002 – Amgen (NASDAQ: AMGN)today announced that it has submitted a supplemental Biologics License Application (sBLA) with the U.S. Food and Drug Administration (FDA) supporting once-weekly dosing of ENBRELâ (etanercept).
“This is another important milestone in the development of ENBREL,” said Dr. Beth Seidenberg, Amgen's senior vice president of development. “Not only does ENBREL have the broadest range of indications to treat rheumatic diseases, but this latest application may offer patients dosing flexibility.”
The filing is based on results from a Phase 3 study demonstrating that patients treated with 50 mg of ENBREL once weekly achieved similar efficacy, tolerability and pharmacokinetics when compared to patients receiving 25 mg of ENBREL twice weekly.
Physicians have become familiar with the benefits and proven long-term tolerability profile of ENBREL. It has been used to treat over 129,000 patients since became commercially available four years ago, making it one of the fastest-growing prescription products ever launched.
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 and RA. The binding of ENBREL to TNF renders the bound TNF biologically inactive, resulting in significant reduction in inflammatory activity.
Important Treatment Considerations
There have been reports of 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.
There have also been rare reports of serious blood disorders, some involving death.
Contact your doctor immediately if you develop symptoms such as persistent fever, bruising, bleeding, or paleness. It is unclear if ENBREL has caused these nervous system or blood disorders. If your doctor confirms serious blood problems, you may need to stop using ENBREL.
The most frequent adverse events in placebo-controlled RA clinical trials involving 349 adults were injection site reactions (ISR) (37%), infections (35%), and headache (17%).
Only the rate of ISR was higher than that of placebo. The most frequent adverse events in a methotrexate-controlled clinical trial of 415 adults with early-stage RA were infections (64%), ISR (34%), and headache (24%). Of these, only the rate of ISR was higher than that of methotrexate. Patients have been observed in clinical trials for over 3 years. The incidence of malignancies has not increased with extended exposure to ENBREL and is similar to the projected background rate.
Adverse events in the psoriatic arthritis trial were similar to those reported in RA clinical trials. In a study of 69 patients with JRA, infections (62%), headache (19%), abdominal pain (19%), vomiting (13%), and nausea (9%) occurred more frequently than in adults. The types of infections reported in JRA patients were generally mild and consistent with those commonly seen in children. Serious adverse reactions reported rarely were chicken pox (3%), gastroenteritis (3%), serious infection (2%), depression/personality disorder (1%), skin ulcer (1%), inflammation in parts of the upper digestive tract (1%), and diabetes (1%).
Amgen and Wyeth Pharmaceuticals, a division of Wyeth, market ENBREL in North America. Other Wyeth affiliates market 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.
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