Roche Seeks US Approval for Arthritis Drug
Swiss drugmaker Roche has submitted its experimental Actemra drug to the U.S. authorities for approval to treat moderate to severe rheumatoid arthritis in adults.
The filing was in line with expectations and follows late-stage clinical trials that showed the drug was effective against the potentially crippling form of arthritis. The drug has the potential to become one of Roche's biggest sellers.
Roche said in a statement on Wednesday it would file for marketing authorization of Actemra with the European Medicines Agency (EMEA) in early December. The company had promised to file the drug for approval by the end of 2007.
Roche's participation certificates, its most widely traded form of equity, were 0.15 percent lower at 199.60 Swiss francs, outperforming the Swiss blue chip index which was down 1.4 percent.
Roche managers have said Actemra should have the same revenue potential as the most popular drugs used now to treat rheumatoid arthritis. They include Abbott Laboratories' $3 billion-a-year Humira.
In addition to having proved effective against rheumatoid arthritis, Actemra has a side effect of correcting anaemia. Roche says Actemra could be tested against a handful of other diseases in the coming year.
Actemra is already sold in Japan by Roche's majority-owned partner Chugai Pharmaceutical to treat Castleman's disease, a rare immune disorder.