Merck’s bid to revitalise its cholesterol portfolio has been dealt a blow as US regulators rejected the firm’s new combination treatment MK-0524A.
The US Food and Drug Administration has issued a not approvable letter for MK-0524A (extended-release niacin/laropiprant) for the treatment of primary hypercholesterolemia or mixed dyslipidemia. The move has taken the firm and analysts by surprise, seeing as how European regulators recommended approval just days before for the drug, which lowers ‘bad’ low-density lipoprotein cholesterol and triglyceride levels, and also increases cardioprotective ‘good’ high-density lipoprotein cholesterol levels .
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By Kevin Grogan
Source: PharmaTimes
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