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MERCK's MEVACOR (LOVASTATIN) FDA APPROVAL IS IMMINENT

Executive Summary

MERCK's MEVACOR (LOVASTATIN) FDA APPROVAL IS IMMINENT, according to signs of preparation at FDA for a major approval announcement. A contingent of MS&D public affairs specialists has been to visit FDA twice in the past three weeks, most recently on July 16 to discuss the approach for a press conference to announce approval of the drug. An FDA public calendar entry notes an initial meeting on Mevacor on June 30. The Merck contingent included two representatives from Merck's Washington office, Robert Ingram and Gerald Kantorow and MS&D public affairs director Anthony Fiskett. Their FDA counterparts were headed by Deputy Commissioner John Norris. Also attending for FDA were a group of top staffers familiar with public affairs and legislative liaisons: Chris Smith and Faye Peterson of the public affairs office, Doug Campbell from legislative affairs, and Special Assistant to the Commissioner Jeffrey Levitt. The pending Mevacor approval is an important event to FDA as well as Merck. The approval could help to counterbalance some of the concerted criticism the agency has been taking, keyed by the editorial page of The Wall Street Journal, since the May 29 Cardio-Renal Advisory Committee review of Genentech's Activase (see related story, p. 3). The rapid approval of Mevacor, which potentially has a much larger appropriate patient population than TPA, could help to restore FDA's image as an approver of new medications. Mevacor has moved through the regulatory review quickly. The NDA was submitted in mid-November; the product went to an advisory committee three months later. It appears to have reached the approval stage five months after the advisory committee review. The public affairs challenge for Merck and FDA in announcing an approval will be to balance the importance of the decision with information about appropriate use of the drug. At the advisory committee meeting, the company took the approach that the drug should be aimed initially at high risk hypercholesterolemic patients. Those patients are defined according to the 1984 NIH conference, as patients over 40 years of age with blood cholesterol levels exceeding 260 mg/dl and those aged 30-39 with levels of 240 mg/dl. The approval is coming at a time of increased public attention to cholesterol levels (see following story). Merck may face a problem keeping the drug within the context of a treatment for high-cholesterol instead of a prophylactic for high cholesterol diets. FDA can be expected to stress diet as well as drug treatment when announcing the approval. FDA and Merck have collaborated on breakthrough-drug press conferences in the past: notably twice in 1981 for the myocardial reinfarction approval for the beta blocker Blocadren and for the first generation hepatitis B vaccine, HeptavaxB.
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