Raptiva receives first approval outside US
Swissmedic, the Swiss regulatory authority, has approved Serono's Raptiva (efalizumab) for the treatment of adult patients with moderate-to-severe plaque psoriasis.
Swissmedic, the Swiss regulatory authority, has approved Serono's Raptiva (efalizumab) for the treatment of adult patients with moderate-to-severe plaque psoriasis.
Raptiva is the first biological therapy for psoriasis to be approved in Switzerland. It is designed to provide continuous control of the disease and can be self-administered by patients as a single, once-weekly, subcutaneous injection.
Raptiva is a humanised therapeutic antibody designed to selectively and reversibly block the activation, reactivation and trafficking of T-cells that lead to the development of psoriasis symptoms. In clinical studies, Raptiva demonstrated a rapid onset of action in the reduction of symptoms associated with psoriasis, in some patients within four weeks of initiating treatment.
Serono has the rights to develop and market Raptiva worldwide outside the US and Japan. Development and marketing rights in the US remain with Genentech and its US partner XOMA. Switzerland is the first country outside of the US to approve Raptiva.
'We are delighted that our home territory of Switzerland is the first country outside of the US to give approval to Raptiva,' said Ernesto Bertarelli, ceo of Serono. 'We look forward to bringing Raptiva to other patients, who deserve a new treatment for this serious condition.' Serono plans to launch Raptiva in Switzerland during the second quarter of 2004.