UPDATE 2-US FDA reviewer backs Astellas-Cardiome drug
(Adds FDA staff comments, Astellas comments, background, byline)
WASHINGTON, Dec 7 (Reuters) - An experimental intravenous drug developed by Astellas Pharma Inc (4503.T) and Cardiome Pharma Corp (COM.TO) should be approved for treating a common heart ailment, a U.S. drug reviewer said in documents released on Friday.
A Food and Drug Administration advisory panel will consider the reviewer's recommendation when it meets on Tuesday to evaluate the drug, called vernakalant.
"The development program provides persuasive demonstration of efficacy, with results substantiated in two independent trials," FDA reviewer Ellis Unger wrote in a memo dated Nov. 13 and released on Friday.
Japan's Astellas and Canada's Cardiome are seeking FDA approval to sell intravenous vernakalant for acute treatment of atrial fibrillation (AF), a condition in which the heart's upper chambers beat abnormally and put patients at risk for clots and strokes.
About 2.2 million Americans have AF, according to the American Heart Association. Many patients have no symptoms, but others experience dizziness, heart palpitations, weakness, shortness of breath and chest pain.
In a summary prepared for the advisory panel of outside expects, FDA staff said the panel would be asked to weigh the relative risks and benefits of vernakalant, as well as Solvay SA's (SOLB.BR) experimental AF drug tedisamil, which goes before the panel on Wednesday. Solvay's proposed brand name for its product is Pulzium.
Both drugs carry some risks that patients may develop other types of abnormal heart beats, FDA staff said.
Unger said the risk of two potentially dangerous abnormal heart rhythms -- ventricular fibrillation and Torsades de pointes -- should be included in the drug's label.
Astellas, in a separate summary, said the rate of adverse cardiac events was low, with two cases of ventricular fibrillation and one of Torsades de pointes.
Both Unger and Astellas said one death was likely related to vernakalant. Unger said that patient's health status should have excluded him or her from the study.
Astellas said overall "the benefits of vernakalant injection outweigh its risks," and there was a need for better AF therapies.
The FDA staff summary said Solvay's experimental intravenous drug causes an abnormally slow heart beat and low blood pressure, and "these are likely to have contributed to the one death in the development program."
"The committee will need to consider the extent to which this risk is understood and managed," the staff said, noting a potential interaction with other therapies that produce those problems.
The slow heart beat and low blood pressure "appear to be less of a problem with vernakalant," FDA staff said.
Solvay spokesman Neil Hirsch said the company "looked forward" to discussing its application at the panel meeting but would not comment in advance.
The advisory panel is expected to make recommendations on whether either or both drugs should be approved. The FDA is expected to issue final rulings on the drugs by Jan. 19. The agency typically follows advisory panel recommendations.
Summaries from FDA staff and Astellas were posted on the agency's Web site here. (Reporting by Lisa Richwine, editing by Mark Porter and John Wallace)
