WASHINGTON (Reuters) - Roche Holding AG's drug Actemra, known generically as tocilizumab, appears to be effective for treating rheumatoid arthritis, U.S. drug reviewers said in a summary released on Friday.
Food and Drug Administration staff said liver enzyme abnormalities were relatively common but most cases were mild to moderate. Effects on liver enzymes and blood fats known as lipids were not associated with health problems in the controlled setting of clinical trials, the summary said.
The risk of infections appeared similar to other drugs that suppress the immune system, the FDA reviewers said.
The FDA staff said they would ask an advisory panel that meets Tuesday whether Actemra's benefits outweigh known and potential risks and if the drug should be approved. Roche bills the drug as a potential blockbuster.
Actemra works differently that other rheumatoid arthritis drugs on the market. It blocks interleukin-6 (IL-6), a protein involved in inflammation.
"The clinical trial experience has been extensive, but may not capture the full extent of safety concerns that may arise with long-term IL-6 inhibition," the FDA staff said.
Roche, in a separate summary, said Actemra was "generally well tolerated" and the potential side effects were "recognizable, reversible and usually not treatment-limiting."
