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About Enbrel (etanercept) ENBREL is a soluble form of a fully human tumor necrosis factor (TNF) receptor with a clinical efficacy and safety profile established over 15 years of collective clinical experience.
Enbrel is currently approved for intermittent treatment of adult plaque psoriasis: if approved by the European Commission following the Committee's recommendation, Enbrel will become the first and only biologic treatment indicated for both continuous and intermittent treatment of adult plaque psoriasis.
Enbrel treats moderate to severe psoriasis, while Mimpara treats symptoms associated with chronic kidney disease.
According to study results at one year, 50 percent of patients (n = 265) with active early moderate-to-severe rheumatoid arthritis who received a combination of ENBREL and methotrexate therapy achieved DAS clinical remission (DAS28 < 2.
ENBREL is indicated for reducing signs and symptoms, keeping joint damage from getting worse and improving physical function in patients with moderate to severe rheumatoid arthritis.
Results from the pioneering PRESTA (Psoriasis Randomized Etanercept STudy in Subjects with Psoriatic Arthritis) study showed that at 24 weeks, two out of three patients with psoriatic arthritis (70% taking 50mg Enbrel twice-weekly and 62% taking 50mg once-weekly) showed a 75% improvement in the psoriasis area-and-severity index (PASI 75)(1).
More than 40 percent of 231 patients receiving a combination of Enbrel and methotrexate, another drug used to treat rheumatoid arthritis, achieved clinical remission.
The Committee recommended, with an 8-5 vote, to approve ENBREL for the treatment of moderate to severe plaque psoriasis in children.
The PRESERVE trial met both its primary and conditional primary endpoints by demonstrating a statistically superior response in moderately active RA patients taking ENBREL 50mg weekly (QW) plus MTX or ENBREL 25mg QW plus MTX compared with those taking MTX monotherapy at 88 weeks.
As discussed in an oral presentation, clinical data showed that ENBREL was effective in treating the signs and symptoms of active AS in significantly more patients than those receiving sulphasalazine, a disease modifying antirheumatic drug (DMARD) and significant differences were reported as early as 2 weeks.
But Yamauchi said patients can inject Enbrel on their own, usually once a week.
Amgen (NASDAQ:AMGN) announced that the supplemental Biologics License Application (sBLA) for ENBREL for the treatment of pediatric patients with chronic moderate to severe plaque psoriasis who have tried another therapy will be discussed today at a meeting of the DODAC.
New Interim Results from the PRESERVE Study Evaluate ENBREL Therapy in Patients with Moderately Active Rheumatoid Arthritis
A study showed that out of 277 patients, 58 percent treated with Enbrel showed significant improvements in pain management and inflammation.
Amgen (NASDAQ: AMGN) and Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), today announced data from a Phase 3 study which showed that children and adolescents with moderate to severe plaque psoriasis who received treatment with ENBREL experienced significant improvements in the signs and symptoms of their disease.
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