Serono to launch study of psoriasis drug Raptiva

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.