MERCK VASOTEC APPROVED FOR CONGESTIVE HEART FAILURE by FDA on June 24. Initially launched in 1986, the ACE inhibitor product previously carried only an antihypertension indication in the U.S., where 1987 retail sales reached $ 156 mil. at pharmacy acquisition cost, according to audit firm Pharmaceutical Data Services (PDS). "Vasotec (enalapril) . . . has been approved by the FDA for use a adjunctive therapy in treating all degrees of heart failure in patients who are not responding adequately to diuretics and digitalis," Merck states in a same-day press release. The company plans to kick off the launch with a July 13 press conference. The new indication is similar to an expanded congestive heart failure claim received by Squibb's Capoten about one month ago ("The Pink Sheet" May 23, T&G-2). The new labeling will allow Merck to actively promote in a segment of the cardiovascular market that was previously off limits. U.S. retail sales of Capoten were $ 230 mil. in 1987 at acquisition cost, according to PDS. Before Capoten's most recent supplemental approval, however, the product had been available as a therapy of last resort for congestive heart failure. In a recent marketing realignment, Squibb split the detailing of Capoten for heart failure and hypertension between its Princeton Pharmaceuticals and E. R. Squibb sales forces, respectively. At an October 1987 meeting, FDA's Cardio-Renal Drugs Advisory Committee unanimously recommended approval of Vasotec for congestive heart failure, with separate labeling claims for both improvement of quality of life and reduction of mortality. The recommendation reflected the committee's conclusion that placebo-controlled studies had established the drug's efficacy in terms of exercise tolerance and survival rates. The committee was particularly impressed by a 35-center Scandinavian study known as the "CONSENSUS Trial," which examined 253 Class IV patients with an average age of 70 years. Merck reported that 50 of 127 patients in the enalapril group died after six months compared to 68 of 126 patients receiving conventional therapy plus a placebo. After enalapril therapy, 38 Class IV patients moved into Class III status, 13 into Class II and three into Class I, compared to 25, two and zero on placebo, respectively. Merck is also seeking a congestive heart failure claim for its second generation ACE inhibitor product Prinivil (lisinopril). At its October meeting, FDA's Cardio-Renal Drugs Advisory Committee requested that the company conduct an additional placebo-controlled trial for lisinopril.
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