Merck’s latest attempt to get the green light to market an over-the-counter version of its old cholesterol-lowering product Mevacor looks doomed after an advisory panel in the USA voted against recommending approval.
The US Food and Drug Administration's joint panel of the Nonprescription Drugs Advisory Committee and the Endocrinologic and Metabolic Drugs Advisory Committee voted 10-2, with one abstention, against recommending approval at this time of OTC use of Mevacor (lovastatin) 20mg taken once-daily.
The panel felt that Merck’s studies supporting the file failed to show that patients can make appropriate assessments about whether they require a cholesterol-lowering drug.The panel’s recommendation echoes the response the New Jersey-based drugmaker has received from the FDA in two previous bids to get approval for OTC Mevacor.
A similar application was made in January 2005 with then-partner Johnson & Johnson and this followed another unsuccessful bid in 2000 to sell an OTC 10mg version of the drug. This time, however, Merck submitted additional data but it would not appear to have done the trick. Edwin Hemwall, vice president of global OTC regulatory and scientific affairs for the firm, said that "we are disappointed in today's outcome [as] we felt we presented a compelling case to the committee”.
The firm still believes that non-prescription Mevacor 20mg would be “a valuable option for motivated consumers who know they have moderately elevated cholesterol and certain risk factors, and are already talking with their healthcare provider", he added.
That view cut no ice with Sidney Wolfe, director of Health Research Group at influential consumer body Public Citizen. In his testimony to the committee, Dr Wolfe said that in the company’s new SELECT study, “the overwhelming majority of patients who, after reading the product label, made a decision on their own to purchase Mevacor, made the wrong decision”.
He added that the contrast between “rational and successful OTC use of analgesics and antihistamines versus a statin such as lovastatin could not be sharper”. For pain and allergies, the ability for people to make an accurate assessment of these symptoms, measure the success of the treatment and to adjust the dose accordingly “is quite clear”, Dr Wolfe noted. “For statins, none of these criteria are met”.
The FDA is not bound by the committee's recommendation, but its final decision, on January 28, is likely to be negative. That will be a blow not only to Merck but also to GlaxoSmithKline which little more than a fortnight ago has acquired exclusive OTC marketing rights in the USA for Mevacor.
Source: PharmaTimes
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