Merck's Cholesterol Trial Win Puzzles as FDA Filing Uncertain
- Drug successfully protected heart after similar drugs failed
- Merck uncertain about filing with FDA, raising questions
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An experimental cholesterol drug developed by Merck & Co. succeeded in reducing heart risks in a late-stage trial, a surprise win for a class of treatments that has failed numerous times in the past.
But the drugmaker said it hasn’t decided whether it would file for approval with the U.S. Food and Drug Administration, puzzling doctors and analysts alike. In a two-paragraph statement on the study Tuesday, Merck did point out that the drug can build up in fat cells -- a potential issue, though consistent with earlier findings that the medicine may persist for years after people stop taking it.