Roche arthritis drug works - US FDA staff

By Lisa Richwine

WASHINGTON (Reuters) - Roche Holding AG's (ROG.VX) drug Actemra appears to help adults with rheumatoid arthritis, U.S. drug reviewers said in a summary released on Friday ahead of a key meeting on the product.

Abnormal liver enzymes were relatively common but most cases were mild to moderate, Food and Drug Administration staff said. The drug's effects on liver enzymes and blood fats known as lipids were not associated with health problems in the clinical trials, the summary said.

The FDA staff said they would ask an advisory panel that meets Tuesday whether the benefits of Actemra, which Roche bills as a potential blockbuster, outweigh known and potential risks and whether the intravenous drug should be approved.

The risk of infections appeared similar to other drugs that suppress the immune system, the FDA reviewers said.

Cancer was reported in some Actemra patients but the rate seemed consistent with the expected level for people with rheumatoid arthritis, they added.

Gastrointestinal perforations "may be slightly elevated" but were "uncommon," the reviewers said.

Roche shares gained 3.5 percent in Swiss trading.

The company is seeking FDA approval to sell Actemra for adults with moderate to severe rheumatoid arthritis.