Serono announced that it has received a unanimous positive opinion from the Committee of Medicinal Products for Human Use (CHMP) recommending approval of its psoriasis product Raptiva (efalizumab).
The positive recommendation has been issued during this week's meeting of the CHMP, the scientific committee that evaluates medicinal products for human use within the EU since the accession of the 10 new member states on May 1, 2004.
Raptiva received the CHMP positive opinion for the 'Treatment of adult patients with moderate to severe chronic plaque psoriasis who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including cyclosporine, methotrexate and PUVA'. Serono expects the European Commission's Marketing Authorisation during the third quarter of this year and plans to initiate the launch of the product in EU countries shortly thereafter.
"The CHMP's positive opinion is very good news for people with psoriasis as Raptiva can offer an effective therapy to those whose needs are not met by current treatments," said Ernesto Bertarelli, CEO of Serono.
Serono received authorisation for Raptiva in Switzerland in March and in Argentina last month and is awaiting the outcomes of marketing applications in a number of other territories for which it is responsible. Raptiva has also been available since November 2003 in the US, where it is marketed by Genentech for the treatment of moderate to severe chronic plaque psoriasis in adults aged 18 or older who are candidates for systemic therapy or phototherapy.
Raptiva is a humanized therapeutic antibody designed to selectively and reversibly block the activation, reactivation and trafficking of T-cells that lead to the development of psoriasis symptoms. Serono has the rights to develop and market Raptiva worldwide outside of the United States and Japan.