UPDATE - US panel wants more data on CV Therapeutics drug
Tuesday December 9, 6:11 pm ET
By Lisa Richwine
(New throughout with panel, company comments background)
GAITHERSBURG, Md., Dec 9 (Reuters) - U.S. regulators should require more research before deciding whether to approve a CV Therapeutics Inc. (NasdaqNM:CVTX - News) experimental drug for treating chronic chest pain, a U.S. advisory panel said on Tuesday.
The Food and Drug Administration will make the final decision on whether to clear the drug, called Ranexa. The agency usually follows the advice of its panels.
Ranexa is the first in a new class of treatments for angina, the chronic chest pain that can precede heart attacks.
The panel debated whether the FDA should approve Ranexa for any angina patient or should restrict use to certain people, such as those who cannot tolerate current therapies.
"If unrestricted (labeling) is desired, more data is needed, and if it's a restricted label, more data is needed," panel chairman Jeffery Borer said in summarizing the panel's opinion.
Members were particularly concerned Ranexa might react with other medicines and cause fainting, Borer said. Many also were worried that the company's studies included mostly white males and suggested more research in a broader population.
Panelists were less concerned the drug might cause potentially dangerous heart rhythms, Borer said.
The FDA highlighted that issue in October when it said Ranexa was "approvable" if additional information answered lingering safety questions.
Dr. Steven Nissen, a panel member and medical director of the Cleveland Clinic's Cardiovascular Coordinating Center, said he was less worried about the drug's safety after hearing the company's presentation.
"I have to give the sponsor credit for putting forth a very convincing case, both for efficacy and for safety. I got reassurance on both sides," he said.
Angina results from an insufficient supply of oxygen to the heart. Researchers believe Ranexa can prevent the problem by enabling the heart to use oxygen more efficiently, the maker said.
The Palo Alto, California-based company, which has no products on the market and lost $32 million in the third quarter, is counting on Ranexa to be its first big seller and to make the company profitable.
Louis Lange, the company's chairman and chief executive, said it was too early to say if the company would need to conduct another clinical trial or to try to predict when the drug might reach the market.
"I think this (panel discussion) opens the door to have a very productive discussion with the FDA," Lange told reporters. "We are very encouraged by the general tenor of the discussion on safety and efficacy."
Trading in the company's shares was halted during the panel meeting. |
