From another site, sounds very wishy-washy (maybe I'll get my "very small position" tomorrow) It just sounds like expensive road blocks.
CV Therapeutics Ranexa Restricted Angina Indication Would Require New Study, Cmte. Says
CV Therapeutics’ Ranexa could receive a restricted indication for use in refractory angina patients with a new study in that population, FDA’s Cardiovascular & Renal Drugs Advisory Committee said Dec. 9.
"It could be approved with a restricted label only if studies were done, appropriate studies, in a population defined…as being resistant to current therapy or highly likely to be resistant to currently available therapy," Committee Chair Jeffrey Borer, MD, Cornell University Weill Medical College, said.
A majority of committee members agreed with FDA that Ranexa should not be approved for unrestricted use due to unresolved safety and dosing issues.
Committee members said they would like to see the sponsor conduct a study in patients who have persistent angina after treatment with at least one other anti-anginal agent or who are intolerant to other anti-anginal therapies. In addition, the committee urged CV Therapeutics to collect more data on use in women and ethnic groups, and patients on concomitant therapies, especially long-acting nitrates.
In its Oct. 30 "approvable" letter, FDA told the company that three safety issues would have to be resolved prior to approval of Ranexa (ranolazine): potential testicular toxicity; clinical implications of prolonged cardiac QT interval; and an insufficient safety database.
In clinical trials, ranolazine was associated with a mean 2-5 msec increase in the QT interval over the proposed dose range; prolongation of the QT interval may lead to the potentially fatal condition of torsade de pointes.
FDA suggested that CV Therapeutics would have to provide "a clear reason to approve a therapy with what appears to be an additional, possibly life-threatening risk." Restricting use of the product to resistant patients would be one way of demonstrating a benefit of ranolazine over other anti-anginal agents.
Committee members were less concerned about the potential of QT prolongation associated with ranolazine to lead to torsade de pointes after presentation of preclinical data by CV Therapeutics showing that the lengthening of the interval does not lead to electrophysiological changes that may cause torsade de pointes.
"I was very impressed with the presentation and I’m really much less concerned about the QT issue than I was when I came in or than I might have been," Borer commented.
However, most committee members did not feel comfortable recommending unrestricted use of the drug because of the potential of torsade de pointes and a variety of other issues. Some committee members wanted longer exposure to the drug in a broader population of patients. Other members requested more information on dosing and the incidence of syncope with the drug.
While the committee settled on restricted use in resistant patients as a more appropriate indication for Ranexa, members pointed out that the drug had not been studied in that group of patients and therefore advised that a new study would have to be performed. |
