Wyeth has received positive recommendations from the European Committee for Medicinal Products for Human Use (CHMP) for two recent submissions relating to Enbrel (etanercept). It’s a tumour necrosis factor alpha inhibitor treatment used for plaque psoriasis, rheumatoid arthritis and other related inflammatory conditions.
Enbrel is currently approved for intermittent treatment of adult plaque psoriasis.
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.
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.
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.