Genentech Says FDA Approves Actemra Arthritis Drug
From Associated Press (January 9, 2010)
SOUTH SAN FRANCISCO, Calif._Biotechnology company Genentech Inc.
says the U.S. Food and Drug Administration has approved its new
drug to treat rheumatoid arthritis.
The approval of the drug, Actemra, "marks a major step forward" in
the treatment of the disease, Hal Barron, chief medical officer for
Genentech and its parent company, the Roche Group, said in a
statement. Development of the drug involved five Phase 3 clinical
studies and more than 4,000 participants in 41 countries, Genentech
said.
Actemra works by blocking the effect of a certain protein
associated with inflammation. But because Actemra acts to suppress
the immune system, it can also have serious side effects, including
severe infections, liver abnormalities and damage to digestive
organs.
Rheumatoid arthritis affects about 1.3 million people in the U.S.,
according to the Arthritis Foundation.
The drug was co-developed with Japan's Chugai Pharmaceutical Co.
and has been approved for use in Japan since 2005. It is also
approved in the European Union, India, Brazil, Switzerland and
Australia.
Posted: January 2010
