Serono to launch study of psoriasis drug Raptiva
Posted on: Monday, 24 July 2006, 07:09 CDT
ZURICH (Reuters) - Swiss pharmaceutical firm Serono said it was launching a study of its Raptiva psoriasis treatment in Europe after U.S. regulators warned recently that a the drug may be linked to a risk of anemia.
Serono said in a statement that the main objective of the seven-year study involving 7,000 adult patients with moderate to severe plaque psoriasis was to gather additional long-term safety data about Raptiva.
"The study will ... provide physicians with additional clinical evidence of the long-term safety profile of Raptiva in psoriasis in clinical practice" a Serono statement quoted Franck Latrille, the company's senior executive vice president global product development as saying.
The study would also help gather data on the long-term safety profile of other treatments for psoriasis.
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 which had failed.
Genentech, which has development and marketing rights for Raptiva in the United States, and the U.S. Food and Drug Administration last week added a warning of the risk of a certain type of anemia occurring with Raptiva.
They also strengthened warnings about the risk of serious infections and decreased blood platelets that may be associated with the drug's use.
Raptiva won U.S. approval in October 2003.
Source: REUTERS
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