Hot on the recent Vytorin debacle comes another disappointment for Merck after the FDA issued a non-approval letter for Cordaptive (MK-0524A) yesterday. The good news, however, was that the EU authorities approved it, but the US market clearly remains sceptical. Merck did not elaborate on the reasons for the FDA's rejection.
Cordaptive is a combination drug that contains an extended-release form of niacin, a vitamin, and a chemical called laropiprant to stop flushing, a dilation of blood vessels that causes redness and an unpleasant burning sensation on the neck and face. Flushing is a common side effect of niacin-based drugs, and the biggest reason many patients stop taking current products, including Niaspan.
Given the failure of Pfizer’s torcetrapib, the current market news is hardly surprising. The Pfizer pill caused unexpected deaths, and a recent Cordaptive study revealed an increase in liver enzymes and had an impact blood sugar for diabetics.
Abbott are likely to be happy with the news - their related cholesterol medication, Simcor, was approved 2 months ago. Simcor was also a combination product, simvastatin and niacin; both components have separately demonstrated an ability to reduce heart attacks and death.
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