Biotech Values

[krenjp]

I didn't read it either but the panel seems more critical of the AE profile than the company had suggested:

"At least one patient in Cardiome's study died as a result of heart spasms that the FDA said were probably triggered by the drug. The agency noted several incidents of dangerously low heart pressure and heart rates among patients taking the drug.

FDA's reviewers also said patients with a history of past heart problems -- prime candidates for the drug -- were not included in the company's study. As a result, the advisers said they would recommend approval of the drug for the patient group studied by the company, but with a warning against use in patients who have a history of heart attack or heart failure."

Cardiome Shares Fall on FDA Scrutiny
Friday December 7, 2:34 pm ET
Cardiome Pharma Shares Fall As FDA Questions Safety of Drug to Treat Irregular Heart Rhythms


WASHINGTON (AP) -- Shares of Canadian drug maker Cardiome Pharma Corp. fell Friday after U.S. regulators released a somewhat critical review of the company's drug to treat irregular heart rhythms.
The Food and Drug Administration said Cardiome's drug vernakalant effectively restores normal heart rhythm in patients experiencing atrial fibrillation, which causes the heart's upper chambers to spastically contract. About 9 percent of people older than 80 experience the condition.

Reviewers questioned whether the drug's safety risks outweigh its benefits, especially since it treats the condition, but doesn't cure it. FDA posted the drug review to its Web site ahead of a meeting Tuesday at which outside heart experts will vote on the drug's merits. The agency is not required to follow the experts' advice, though it usually does.

At least one patient in Cardiome's study died as a result of heart spasms that the FDA said were probably triggered by the drug. The agency noted several incidents of dangerously low heart pressure and heart rates among patients taking the drug.

FDA's reviewers also said patients with a history of past heart problems -- prime candidates for the drug -- were not included in the company's study. As a result, the advisers said they would recommend approval of the drug for the patient group studied by the company, but with a warning against use in patients who have a history of heart attack or heart failure.

The FDA is scheduled to make its final decision on vernakalant in mid-January 2008. If the drug is approved, Japanese drug maker Astellas Pharma will have exclusive marketing rights in North America, under an agreement signed with Cardiome in 2003.