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GERMANTOWN, M.D. -- May 15, 2006 -- Advancis Pharmaceutical Corporation today announced that the U.S. Food and Drug ...
Fuente del Material: PSLGroup
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Biologic Enbrel(R) (Entanercept) Available in Easy-to-Use, Prefilled Syringe - 08/10/2006 09:58:47 AM
No Pre-Mixing, Convenient Weekly Dosing Are Significant Benefits, Especially For Arthritis Patients.

MISSISSAUGA, CANADA -- August 10, 2006 -- Biologic therapy Enbrel® (entanercept), used in the treatment of various forms of arthritis and moderate to severe plaque psoriasis, is now available in a new, easy-to-use prefilled syringe, eliminating the need to reconstitute Enbrel in a vial before each injection.

The new prefilled syringe contains a full 50 mg weekly maintenance dose of Enbrel, unlike the previous vials which contain 25 mg requiring two injections a week.

"The introduction of biologic therapies like Enbrel has brought significant advances in our ability to manage these debilitating diseases," said Boulos Haraoui, Clinical Associate Professor of Medicine at the Université de Montréal and head of the Clinical Research Unit in Rheumatology at the Centre Hospitalier de l'Université de Montréal. "A prefilled syringe delivery system and the move to once weekly dosing simplifies treatment and offers a significant benefit to patients."

Enbrel belongs to a class of medications called tumour necrosis factor (TNF) inhibitors. 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 are involved in the inflammatory process. The binding of Enbrel to TNF renders it biologically inactive, resulting in significant reduction in inflammatory activity.

Other than injection site reactions, no adverse events occurred at increased frequency with Enbrel compared to respective control groups in trials.

Most recently, in December 2005, Enbrel was approved by Health Canada for the treatment of chronic moderate to severe plaque psoriasis. It was first approved in Canada in 2000 for adults with rheumatoid arthritis, and approvals followed for treatment of juvenile rheumatoid arthritis in 2003, psoriatic arthritis in 2004 and ankylosing spondylitis in early 2005. More than 337,000 patients worldwide have used Enbrel, and it has more than 450,000 patient-years of post-market exposure.
The current, lyophilized vial administration system will continue to be available. In either the prefilled syringe or lyophilized vial formulation, Enbrel is self-administered by patients or given by a health care provider. For patients with rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis, the recommended dose of Enbrel for adults is 50 mg per week given as one injection. For those with psoriasis, the recommended starting dose of Enbrel for adult patients is 50 mg twice weekly for three months followed by 50 mg once weekly. The recommended dose of Enbrel for children with juvenile rheumatoid arthritis is based on body weight.

Amgen Canada and Wyeth Canada market Enbrel in Canada. Immunex Corporation, a wholly owned subsidiary of Amgen, manufactures Enbrel.

SOURCE: Amgen Canada Inc. and Wyeth Canada
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