The Wall Street Journal-20080216-FDA Clears Abbott-s Combination Heart Drug

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FDA Clears Abbott's Combination Heart Drug

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The Food and Drug Administration granted Abbott Laboratories approval for Simcor, a drug that raises "good" cholesterol and lowers both "bad" cholesterol and triglycerides.

Simcor is a combination of two existing, approved treatments: simvastatin, a statin, and Abbott's Niaspan, an extended-release version of niacin, a B vitamin. Simcor's approval is the first for a cholesterol drug since questions cropped up about the effectiveness of another treatment, Merck & Co. and Schering-Plough Corp.'s Vytorin, and could augur well for FDA approval of Merck's Cordaptive cholesterol-lowering drug, which also is based on niacin.

Statin treatments lower LDL, or bad cholesterol, but don't treat HDL -- good cholesterol -- or triglycerides, two other types of lipids associated with cardiac problems if found at abnormal levels. "Simcor is really the first product that allows physicians to treat all three of the lipids at the same time," said Jim Stolzenbach, head of clinical development for dyslipidemia at Abbott. Abbott said it expects annual sales of Simcor to hit $500 million.

In the data presented to the FDA, 640 patients were started on simvastatin, and then added Niaspan to their regimen. After 24 weeks, patients experienced a 21% increase in HDL, compared with 8% on simvastatin alone; a 12% decrease in LDL above the 7% that they experienced on simvastatin alone; and a 27% decrease in triglycerides, compared with 15% on simvastatin alone.

The question with Simcor is whether the treatment will be any better at preventing heart attacks or death than the components of the medication alone, the same question that Merck and Schering-Plough face with Vytorin. The two components of Simcor have separately demonstrated an ability to reduce heart attacks and death. It also remains to be seen how many patients will actually make the switch to a combination treatment.

Abbott, of Abbott Park, Ill., said it is conducting a study investigating whether Simcor is better than simvastatin or Niaspan alone, but results won't be available until 2011.