OTC Mevacor CUSTOM Label Illustrates New Approach Toward Approval
This article was originally published in The Tan Sheet
Executive Summary
Proposed labeling used in J&J/Merck's actual use trial for OTC Mevacor (lovastatin 20 mg) directs individuals to obtain follow-up cholesterol testing sooner than did the firm's 2000 proposal for the switch
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Proposed labeling used in J&J/Merck's actual use trial for OTC Mevacor (lovastatin 20 mg) directs individuals to obtain follow-up cholesterol testing sooner than did the firm's 2000 proposal for the switch. The Consumer Use Study of OTC Mevacor (CUSTOM) label instructs consumers to seek testing after six weeks of treatment and stop taking the medication and see a doctor if their LDL cholesterol exceeds 129 mg/dL (1 (Also see "Mevacor OTC Actual-Use Study Data May Answer Future NDAC Questions" - Pink Sheet, 15 Nov, 2004.), p. 9). If the consumer's cholesterol is below 129 mg/dL, the statin is "working." The consumer should "keep taking [Mevacor OTC] daily and test your cholesterol once a year," the label instructs. Consumers are advised to eat a healthy diet and exercise, and are cautioned that if they stop taking the drug, "your cholesterol will go back up." In contrast, labeling for 10 mg lovastatin in J&J/Merck's 2000 Rx-to-OTC switch application advised the consumer to test his or her cholesterol "after about eight weeks," and continue using the lovastatin product in combination with a low-fat diet and exercise "or your cholesterol may go back up." The more comprehensive CUSTOM label reflects both the higher dose and more specified intermediate risk population associated with 20 mg lovastatin. The product targets a narrower range of potential users with LDL cholesterol in the 130-170 mg/dL range, plus one or more CHD risk factors (e.g. smoking, high blood pressure and HDL cholesterol below 39 mg/dL). In contrast, lovastatin 10 mg labeling targeted consumers with LDL above 130 mg/dL without mentioning specific risk factors. This more specified group still could represent a sizeable percentage of the U.S. population, Thomas Pearson, MD/PhD, University of Rochester, notes in a Nov. 4 American Journal of Cardiology supplement. Based on data from the third National Health & Nutrition Examination Survey (1988-1992), Pearson estimates approximately 30% of U.S. adults could be candidates for OTC statins, assuming the absence of coronary artery disease and a total cholesterol in the 200 to 239 mg/dL range. The researcher concludes this group "would eventually contribute to approximately one third of CAD cases" if untreated. |