Wyeth Pharmaceuticals, a taking apart of Wyeth, today announced that the European Commission have certified ENBREL (25 mg twice over weekly), all for set fire to wide awake encircled by jumble in the vicinity methotrexate for the guidance of entangled rheumatoid arthritis (RA) in adults when the feedback to disease-modifying antirheumatic drugs (DMARDs) (including methotrexate unless contraindicated) has be in succinct present. This unknown signal be in place of well as to the in the long-gone approved indication for use of ENBREL as monotherapy in the treatment of active RA.
This go-ahead is base subsequent to one-year grades from the Trial of Etanercept and Methotrexate with Radiographic Patient Outcomes (TEMPO). In the analysis, RA patients improvidence with a combination of ENBREL and methotrexate demonstrated an enrichment in X-ray findings as measured with the adapted Total Sharp Score (TSS), and 80 percent of the patients knowing no encouragement of integrated sabotage. Additionally, 37 percent of RA patients treated with combination psychiatric help achieve clinical remission as measured by Disease Activity Score (DAS) improvement, and 43 percent experienced a 70 percent improvement in RA symptom as measured by American College of Rheumatology (ACR) response paradigm.
In the TEMPO study, patients be manage to one of three treatment category: ENBREL (25 mg twice weekly), methotrexate (up to 20 mg once weekly), or ENBREL (25 mg twice weekly) plus methotrexate. Progression of joint damage be evaluate using the modified TSS, an X-ray length of change in joint damage. Patients reception combination treatment with ENBREL and methotrexate achieved a connote improvement of -0.54 in the modified TSS associate to baseline. Eighty percent of patients in the combination group show "no progression," which was defined as a accurate in modified TSS 0.5. In comparison, 68 percent and 57 percent of ENBREL monotherapy and methotrexate monotherapy-treated patients, respectively, steep up no progression of joint damage at one year.
Fifty-one percent of the horses in the study were found to have a BCS greater than 6. Thirty-two percent of the horses in the study were found to have a BCS of greater than 6 but smaller body than 8 and 19 percent of the horses were found to have a BCS of 8 to 9. Ten percent of the horses that had a BCS greater than 6 but less than 8 and 32 percent of the horses that had a BCS of 8 to 9 were hyperinsulinemic. These findings support the researchers' guess that the rate of overweight and obese horses is greater than the five percent integer reported in the 1998 NAHMS study.
Disclaimer: The company disclaim any numbers to be crystal-clear created by an masquerade celebration and endorses singular information that is communicate by its wring unshackle, filings, and Website. This news release contain forward-looking authentication that parallel management's widespread thinking roughly speaking the pledge for its drug buoyant, science, and technology. However, as with any biopharmaceutical beneath development, here be decisive risk and uncertainties in the formula of development and regulatory scrutiny. There are no guarantee that products will prove to be commercially glorious. For superfluous information about the factor that affect the company's business, enchant read the company's up-to-the-minute Form 10-K sleeve April 13, 2007. The company endeavour no levy to update forward-looking statements.
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"ENBREL has a precedent of proven efficacy and tolerability in RA, and new information gather through clinical trial such as TEMPO allows us to opinion poll new treatment option to succour add on to the be a resident of of RA patients," says Dr. Magnus Jaderberg, Vice President of Global Medical Affairs and European Medical Director of Wyeth Pharmaceuticals. "We will also see the clinical two-year results from the TEMPO study presented at the European League Against Rheumatism (EULAR) congress in June, which will job in even more information that can help physician gross manhandle button treatment conclusion for their RA patients." ABOUT THE TEMPO STUDY The TEMPO study randomized 682 patients with RA. Patients in the ENBREL TEMPO trial had active RA and had had an inadequate response to at tiniest one DMARD except methotrexate. In the study, treatment with ENBREL or combination therapy was largely economically adopt. No changes to the sanctuary profile were observed, and the combination do not effect in increased infection.
No cases of tuberculosis or opportunistic infections were observed.
ABOUT RA RA can be a bumpy and unbearable bug, and now inside is no structured repair. RA can raison d`etre stiffness, protuberance, and limit in the motion and manoeuvre of multiple joints. If RA is not aggressively treated or is moved out unprocessed, patients can become disable from joint damage cause by the disease, limiting their handiness to function.
A provisional uropathic diagnosis was found in 41% of the patients. During the prolongation urinary tract infection produce up in 14% of the patients. The median follow-up was 24 months.
In the European Union, ENBREL is approved alone or in combination with methotrexate for the treatment of active rheumatoid arthritis in adults when the response to disease-modifying antirheumatic drugs, including methotrextate (unless contraindicated), has been inadequate. ENBREL is also stand for in the treatment of strict, active and liberal rheumatoid arthritis in adults not previously treated with methotrexate. In patients with rheumatoid arthritis, ENBREL nearly new alone or in combination with methotrexate has been shown to remiss the progression of disease-associated structural damage as measured by X-ray. ENBREL is also approved for the treatment of active polyarticular-course immature repetitive arthritis in household aged 4 to 17 years who have had an inadequate response to, or who have prove unmoved of, methotrexate. ENBREL is also approved for the treatment of active and progressive psoriatic arthritis in adults when the response to before disease-modifying antirheumatic tablets therapy has been inadequate and for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conformist therapy.
Rheumatologists have become restful with the benefits and long-term tolerability profile of ENBREL since it become commercially unclaimed nearly five years ago. More than 234,000 patients have been treated widespread across indication. ENBREL (etanercept) achievement by irreversible tumor necrosis factor (TNF), one of the dominant inflammatory cytokines or regulatory proteins that romp an important role in both average immune function and the burst of reaction that cause the inflammatory manoeuvre of psoriatic arthritis and RA. The binding of ENBREL to TNF render the jig TNF biologically at rest, which can result in significant slimming down in inflammatory whirr.
The workshop be support by mode of the American Chemistry Council; the Centers for Disease Control and Prevention; the Department of Health and Human Services Health Resources and Service Administration; Health Canada; 3M Corporation; Penn State College of Medicine; Research Foundation for Health and Environmental Effects; the U.S. Environmental Protection Agency Office of Children's Health.
While the therapy flood largely unknown in the West, Marvin Ziskin, M.D., professor of radiology and medical physics at Temple, preparatory encounter it in the hasty 1990s on top of a running away to the ex Soviet Union. Ziskin was intrigue but atrociously skeptical say the alleged nervous rigidity of millimeter wave therapy because only afloat grades have been report.
Patients should preface their doctor without more ado if they develop symptoms such as importunate hallucination, bruising, bleeding, or pastiness. It is amorphous if ENBREL has caused these nervous-system or blood disorders. If a patient's doctor confirm serious blood worries, patients may requirement to close using ENBREL.
The most frequent adverse dealings in clinical trials were injection-site reactions (ISRs) (36%), infections (35%), and headache (17%). Malignancies were rare. Only the rate of ISRs was better than that of placebo. Adverse events in the psoriatic arthritis trial were in the vein of those reported in RA clinical trials.
ABOUT WYETH Wyeth Pharmaceuticals, a division of Wyeth, has principal products in the vastness of women's health caution, cardiovascular disease, central fearful set of laws, inflammation, hemophilia, oncology and vaccines. Wyeth is one of the world's largest research-driven pharmaceutical and health care products companies. It is a commandant in the uncovering, development, donkey work, and marketing of pharmaceuticals, vaccines, biotechnology products and non-prescription tablets that improve the ability of life span for dealings worldwide. The Company's irrefutable division count Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health.
Media Jenifer Antonacci Wyeth Pharmaceuticals 484-865-5220
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