CV Therapeutics and FDA Agree to Special Protocol Assessment for Approval-Enabling Study of Ranexa(TM)
June 02 2004 - 5:05PM
PR Newswire (US)
CV Therapeutics and FDA Agree to Special Protocol Assessment for
Approval-Enabling Study of Ranexa(TM) - Management to Host
Conference Call Today at 5:30 p.m. EDT/2:30 p.m. PDT - PALO ALTO,
Calif., June 2 /PRNewswire-FirstCall/ -- CV Therapeutics, Inc.
(NASDAQ:CVTX) announced today that the company and the U.S. Food
and Drug Administration (FDA) have reached written agreement on a
protocol for a clinical trial of Ranexa(TM) (ranolazine) which, if
successful, would support the approval of Ranexa for the treatment
of chronic angina in a restricted patient population. This
agreement was reached under the FDA's special protocol assessment
(SPA) process. "We have been working closely with the FDA to reach
agreement on a study that, if successful, would support the
approval of Ranexa in the United States, and we are pleased to have
reached agreement under the SPA process for a single
approval-enabling study. We anticipate being able to begin
enrollment in this study in the third quarter. We also plan to
initiate at least one additional clinical trial later this year to
support approval of Ranexa in a broader patient population," said
Louis G. Lange, M.D., Ph.D., chairman and chief executive officer
of CV Therapeutics. If approved, Ranexa would represent the first
new class of anti-anginal therapy in the United States in more than
25 years. Chronic angina is a serious and debilitating heart
condition, usually associated with coronary artery disease and
marked by repeated and sometimes unpredictable attacks of chest
pain. It affects approximately 6.8 million people in the United
States. Study Details The study will be a multi-national,
double-blind, randomized, placebo-controlled, parallel group study
to evaluate the effectiveness of Ranexa (1000 mg twice daily) in
approximately 500 patients with chronic angina who remain
symptomatic despite daily treatment with the maximum labeled dose
of amlodipine (10 mg daily), a calcium channel blocker approved for
the treatment of chronic angina. Eligible patients will be
randomized to receive Ranexa 1000 mg or placebo twice daily, in
addition to a daily dose of 10 mg of amlodipine, during a six week
assessment period. The primary efficacy endpoint of the study will
be angina frequency. Based on the reduction in angina frequency
observed in the Phase III CARISA study, this approval-enabling
study is calculated to be 95 percent powered to detect a
statistically significant reduction in angina frequency due to
Ranexa. In CARISA, Ranexa (1000 mg) reduced the frequency of angina
by an average of 1.2 attacks per week, compared to placebo (p
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