In late April of 2008, FDA rejected Merck's application to market CorTredaptive, a fixed dose combination pill of laropiprant and niacin. Now laropiprant, mixed with nicotinic acid (also known as niacin, to us lay folk), is available as a would-be second-line cholesterol management drug (in cases where statins are not well-tolerated, for example) in England (and the rest of the EU, earlier):
. . . .A second-line treatment for dyslipidaemia has been launched in the UK by Merck Sharpe & Dohme. . . . Tredaptive contains nicotinic acid 1000mg and laropiprant 20mg. . . .
The FDA found that some side effects of the laropiprant portion were problematic, as were marginal surrogate-endpoint data sets, in lieu of actual outcomes data, if my memory serves. At the time, Whitehouse Station said that it would find an appropriate time -- in the future -- to re-start with FDA. We shall see, but I'd hope that FDA would continue to insist on a favorable outcome in THRIVE, a study not due to be complete until 2013, as a primary gating variable, in the United States for this combination therapy.
No comments:
Post a Comment