MAIDENHEAD, England, June 4 /PRNewswire/ --
- CHMP Recommends Approval of a Continuous Dosing Regimen Option for Enbrel In Plaque Psoriasis, and a New Pre-Filled Pen Delivery Device
Today, Wyeth received positive recommendations from the European Committee for Medicinal Products for Human Use (CHMP) for two recent submissions relating to Enbrel(R) (etanercept), the tumour necrosis factor alpha inhibitor treatment for plaque psoriasis, rheumatoid arthritis and other related inflammatory conditions.
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.
The CHMP provided its positive recommendation of a continuous dosing regimen for Enbrel based on data from the CRYSTEL and other trials. The CRYSTEL trial examined the efficacy and safety of Enbrel using continuous or intermittent dosing regimens for up to 54 weeks. If approved, the new indication will give physicians, together with their patients, the opportunity and flexibility to tailor treatment regimens in response to the severity of the patient's psoriasis and their ongoing response to treatment.
The new dosage recommendations for adult plaque psoriasis reads:
The recommended dose of Enbrel is 25 mg administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly may be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly. Treatment with Enbrel should continue until remission is achieved, for up to 24 weeks. Continuous therapy beyond 24 weeks may be appropriate for some adult patients. Treatment should be discontinued in patients who show no response after 12 weeks. If re-treatment with Enbrel is indicated, the same guidance on treatment duration should be followed. The dose should be 25 mg twice weekly or 50 mg once weekly.
Results from the CRYSTEL study demonstrated that patients in the continuous and intermittent treatment groups experienced significant improvement in their conditions from baseline and both groups were highly satisfied with the result of their treatment. There were no new safety signals in either the continuous or intermittent treatment groups.
In addition, the CHMP recommended the approval of a new 50mg pre-filled pen (MYCLIC) for the delivery of Enbrel solution for injection. If approved by the European Commission following the positive recommendation, the new MYCLIC pen, may be particularly useful for patients who have a fear of needles or who find using the syringe difficult. Features of the pen include an innovative safety system to prevent accidental misfires, a large inspection window to allow patients to visually confirm drug delivery, and two audible clicks to confirm the start and end of the injection.
Commenting on the new CHMP recommendation for the psoriasis dosing regimen, Dr Michael Zaiac, Assistant Vice President, Immunology, Wyeth Europa said: This is a significant step towards improving the management of what can be a disabling and potentially stigmatising condition. It is hoped that the sustained efficacy achieved with Enbrel in both the continuous and intermittent dosing options will allow for greater individualised approach to psoriasis patient care. With regard to the CHMP recommendation for the new pre-filled pen, Dr Zaiac commented: This will allow a more convenient and simple administration of Enbrel, with the potential for improved patient benefits.
In the European Union, Enbrel has been proven to be effective in, and is Approved for, the treatment of rheumatoid arthritis, plaque psoriasis, paediatric plaque psoriasis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis and ankylosing spondylitis.
Please note a photograph of the MYCLIC device is available on request
Notes to Editors
Enbrel is a fully human soluble tumour necrosis factor (TNF) receptor. Enbrel was first approved in the EU in 2000 for moderate to severe rheumatoid arthritis and polyarticular juvenile idiopathic arthritis, and has since been used in 505,000 patients worldwide across indications.
Enbrel in the EU is approved for the following indications:
Enbrel in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults when the response to disease-modifying antirheumatic drugs, including methotrexate (unless contraindicated), has been inadequate.
Enbrel can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
Enbrel is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.
Enbrel, alone or in combination with methotrexate, has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function.
Polyarticular juvenile idiopathic arthritis
Treatment of active polyarticular juvenile idiopathic arthritis in children and adolescents from the age of 4 years who have had an inadequate response to, or who have proved intolerant of, methotrexate. Enbrel has not been studied in children aged less than 4 years.
Treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic drug therapy has been inadequate. Enbrel has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease.
Treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.
Treatment of adults with moderate to severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including ciclosporin, methotrexate or PUVA.
Paediatric plaque psoriasis
Treatment of chronic severe plaque psoriasis in children and adolescents from the age of 8 years who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.
Wyeth is one of the world's largest research-based pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing, and marketing of prescription drugs and over-the-counter medications. It is also a global leader in vaccines, biotechnology and animal health care.
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For further information, please contact: Wyeth: Gill Markham, Communications - Europe, Middle East and Africa, Direct Tel: +44(0)1628-692536, Mob: +44(0)777-082-7753, Email: email@example.com