Roche's Actemra linked to 15 deaths

Roche's Japanese unit has grim news today: Chugai Pharmaceutical said a study showed its rheumatoid arthritis treatment Actemra might be linked to the deaths of 15 Japanese patients. Severe side effects were reported in more than 200 patients.

A Chugai spokesman told the Wall Street Journal that it will continue to sell the drug, providing more information so doctors will better understand its potential side effects. "We can't deny that there is a causal relationship," the Chugai spokesman said.

Chugai studied nearly 5,000 patients as required by Japanese officials when the drug was approved, and the company uncovered 15 deaths and 221 adverse reactions. The company said the death rate was the same as in clinical trials and similar to competing meds. Nonetheless, the news is a setback; as the WSJ notes, hopes had been high for Actemra because it was designed not only to relieve pain as other RA meds do, but also to inhibit the acute inflammatory response that underlies the disease.

Roche owns 60 percent of Chugai, and the two companies co-market Actemra in Germany, France and the U.K. Roche handles Actemra marketing solo in several other European markets. Chugai expects Actemra sales to reach $157.3 million in 2009, more than twice its 2008 sales.

- read the WSJ story [1]

Related Articles:
Advisory Panel recommends Actemra to FDA [2]
Roche posts new data backing Actemra for RA [3]
Japan OKs Roche's Actemra [4]
Roche seeks FDA approval of RA drug Actemra [5]
Roche sees positive late-stage data on Actemra [6]