this may have something to do with its rise...
ENBREL(R) Is First Biologic Treatment Submitted to FDA for Ankylosing Spondylitis
PR NEWSWIRE - January 22, 2003 08:00
THOUSAND OAKS, Calif., Jan 22, 2003 /PRNewswire-FirstCall via COMTEX/ -- Amgen (Nasdaq: AMGN) today announced that it has submitted a supplemental Biologics License Application (sBLA) with the U.S. Food and Drug Administration (FDA) seeking to expand the labeling of ENBREL(R) (etanercept) to treat a fourth inflammatory disease, ankylosing spondylitis (AS). Currently there are no treatments approved by the FDA, other than non-steroidal anti-inflammatory agents, to treat this chronic disease.
Ankylosing spondylitis is a chronic inflammatory disease predominantly affecting the spine that results in pain and stiffness and can result in partial or complete fusion of the spine, thereby impacting patients' daily activities.
The sBLA is based on three clinical trials, including the results of a Phase 3, multi-center, placebo controlled study of 277 patients with active ankylosing spondylitis, 138 of whom were treated with ENBREL (25 mg twice weekly) over a 6-month period. The primary endpoint of the study was the percentage of patients achieving the Assessment in Ankylosing Spondylitis Response Criteria, a composite measure which includes back pain, inflammation and physical function. The results of this study confirm the findings from an earlier Phase 2 study.
"There was a significant response to ENBREL in the Phase 3 clinical trial, with some patients achieving relief from back pain and stiffness in as early as 2 weeks and with nearly 60 percent of patients meeting the primary endpoint after 6 months compared to 23 percent of patients receiving placebo," said Dr. Beth Seidenberg, Amgen's senior vice president of development. "We are particularly encouraged because this is the first study of any therapeutic in which patients experienced an improvement in range of motion of their spine."
Adverse events were similar to those reported in the rheumatoid arthritis clinical trials, as described below.
"We are pleased that patients with a wide range of important medical diseases are benefiting from the impact of ENBREL," said Kevin Young, general manager and vice president of Amgen's inflammation business unit. "ENBREL is the only TNF inhibitor approved to treat rheumatoid arthritis, juvenile rheumatoid arthritis and psoriatic arthritis and now is the first biologic therapy submitted for approval to treat AS. We continue to demonstrate our commitment to patients and rheumatologists, addressing challenges they face in battling inflammatory diseases."
ABOUT ANKYLOSING SPONDYLITIS
Ankylosing spondylitis is a painful, progressive inflammatory disease affecting the spine and the joints and ligaments that normally allow a person's back to move and flex. The disease frequently begins in the lower back and, with time, may progress into the upper spine, chest and neck. The spine can then fuse, causing loss of motion and deformity. AS may also involve other joints, such as the hips, shoulders, knees, and ankles.
Ankylosing spondylitis belongs to a family of related inflammatory diseases that affect the spine, which is estimated to affect over a million patients.
ABOUT ENBREL
ENBREL is the only fully human anti-TNF receptor approved for use to reduce the signs and symptoms of active arthritis in patients with psoriatic arthritis, and to reduce the signs and symptoms and inhibit the progression of structural damage in patients with moderately to severely active rheumatoid arthritis (RA). ENBREL is the only biologic therapy approved to treat newly diagnosed RA patients, and can be used alone. It is also 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.
Physicians have become familiar with the benefits and proven long-term tolerability profile of ENBREL. It has been used to treat over 130,000 patients worldwide since becoming 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
SINCE THE PRODUCT WAS FIRST INTRODUCED, SERIOUS INFECTIONS, SOME INVOLVING DEATH, HAVE BEEN REPORTED IN PATIENTS USING ENBREL. MANY OF THESE INFECTIONS OCCURRED IN PATIENTS WHO WERE PRONE TO INFECTIONS, SUCH AS THOSE WITH ADVANCED OR POORLY CONTROLLED DIABETES. RARE CASES OF TUBERCULOSIS HAVE ALSO BEEN REPORTED. ENBREL SHOULD BE DISCONTINUED IN PATIENTS WITH SERIOUS INFECTIONS. DO NOT START ENBREL IF YOU HAVE AN INFECTION OF ANY TYPE OR IF YOU HAVE AN ALLERGY TO ENBREL OR ITS COMPONENTS. ENBREL SHOULD BE USED WITH CAUTION IN PATIENTS PRONE TO INFECTION. CONTACT YOUR PHYSICIAN IF YOU HAVE ANY QUESTIONS ABOUT ENBREL OR INFECTIONS.
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(R) (etanercept). 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%).
Please see full Prescribing Information.
Amgen and Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), market ENBREL in North America. Other Wyeth affiliates market ENBREL outside of North America. Immunex Corporation 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).
This news release contains forward-looking statements that involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including our most recent Form 10-Q. Amgen conducts research in the biotechnology/pharmaceutical field where movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate will be successful and become a commercial product.
Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. In addition, sales of our products are affected by reimbursement policies imposed by third party payors, including governments, private insurance plans and managed care providers. These government regulations and reimbursement policies may affect the development, usage and pricing of our products.
In addition, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors.
Because forward-looking statements involve risks and uncertainties, actual results may differ materially from current results expected by Amgen. Amgen is providing this information as of January 22, 2003, and expressly disclaims any duty to update information contained in this press release.
Amgen is a global biotechnology company that discovers, develops, manufactures and markets important human therapeutics based on advances in cellular and molecular biology.
CONTACT: Amgen, Thousand Oaks Jeff Richardson, 805/447-3227 (media) Rebecca Hamm, 805/447-3872 (media) Cary Rosansky, 805/447-4634 (investors)
SOURCE Amgen
CONTACT: media, Jeff Richardson, +1-805-447-3227, or Rebecca Hamm, +1-805-447-3872, or investors, Cary Rosansky, +1-805-447-4634, all of Amgen
URL: enbrel.com
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