SERONO TO BEGIN LONG-TERM SAFETY STUDY OF RAPTIVA

Serono has announced it is launching a study of its Raptiva psoriasis treatment in Europe after U.S. regulators warned recently that the drug may be linked to a risk of anemia. The company said that the main objective of the seven-year study involving 7,000 adult patients with moderate to severe plaque psoriasis is to gather additional long-term safety data about the drug. The study would be carried out in dermatology centers in European hospitals as well as in private dermatology clinics.

Serono has said Raptiva is successful in patients with moderate to severe plaque psoriasis, a skin condition noted for its red and scaly patches, and in patients who had undergone earlier treatments and had failed.

Genentech, which has development and marketing rights for Raptiva in the United States, and the FDA recently added a warning of the risk of a certain type of anemia occurring with Raptiva use. They also strengthened warnings about the risk of serious infections and decreased blood platelets that may be associated with the drug.