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Dow Jones Business News FDA May Require More Trials of CV Therapeutics` Ranexa Monday December 8, 11:16 am ET By Hollister H. Hovey NEW YORK -- Shares of CV Therapeutics slumped after documents from Food and Drug Administration (News - Websites) staff said the company may need to run more clinical trials of its angina drug Ranexa before it can be approved. ADVERTISEMENT The FDA`s Cardiac and Renal Drugs Advisory Committee will discuss CV Therapeutics` marketing application for Ranexa on Tuesday, but the agency posted its analyses of the data on its Web site Monday. "Consideration of the potential benefit ... vs. risk ... leads the reviewer to ask for additional data prior to any approval," the FDA`s documents said. The advisory committee will discuss the company`s data and the agency`s take on it and give the FDA a recommendation, which it usually will accept. At about 11 a.m. EST on the Nasdaq Stock Market (News - Websites) , shares of CV Therapeutics were down $3.69, or 22%, at $13.07 on volume of 8.5 million. The daily average is 1.4 million. The stock earlier fell to a 52-week low of $12.51. According to the FDA documents, the agency is asking the company to perform " an appropriately sized outcomes trial showing an improved survival" comparing the drug to placebo. The FDA said CV Therapeutics could run that study on patients who have failed other angina drugs. The company also needs to clarify appropriate dosing, the agency said, and will ask CV Therapeutics to evaluate how well the drug works in women. "The sponsor could, potentially, incorporate some type of gender evaluation in a study of refractory patients," the documents said. In addition, the FDA has concerns about side effects, most notably the increase the so-called QTc interval, or the time between heart beats that occurred during the clinical trial. There were incidences of a three- to nine- millisecond increase in the QTc interval compared with a placebo in both of the company`s large clinical trials. If the time between heart beats is extended too long, the result could be sudden cardiac death. The FDA is also concerned about drug interactions. First Albany analyst David Webber said in a research note Monday he expects the stock to trade in the $10 to $13 range if the FDA voiced strong concerns about the QTc interval, which it has. He doesn`t own shares of CV Therapeutics, but First Albany did act as co-manager of the company`s most-recent convertible- debt offering. In late October, CV Therapeutics received an approvable letter from the FDA, indicating that the agency thinks the drug works. In August, the company and the advisory panel canceled a review planned for September, citing a need for ongoing talks and more time to put together documents. CV Therapeutics` shares lost more than 25% of their value on the news, which also prompted a shareholder lawsuit. The cancellation of that meeting, which the FDA had scheduled for Sept. 15-16, had no bearing on the fact that the agency had to decide by Thursday whether to approve Ranexa. But most analysts thought the chances of receiving approval were slim without an advisory-board meeting. However, investors sent the company`s stock soaring Oct. 23, when the company said the FDA panel would review Ranexa on Dec. 9 despite the fact there was no new scientific data about the QTc levels made public. If approved, Ranexa would represent the first new class of antiangina therapy in more than 20 years. Ranexa is meant to change the heart`s metabolism so that it uses up sugars more than lipids. Company officials weren`t immediately available to comment. -By Hollister H. Hovey; Dow Jones Newswires; 201-938-5287; hollister.hovey@dowjones.com |
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| aus der Diskussion: | +++ CV Therapeutics Inc (CVTX) - Kurssturz +++ |
| Autor (Datum des Eintrages): | kosto1929 (08.12.03 17:38:26) |
| Beitrag: | 8 von 470 (ID:11550083) |
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