Kenilworth’s Anacetrapib Program Gets Some Very Good News — On CETP REVEAL Outcomes

For almost as long as I’ve been writing this blog (as the prediction in the old graphic, at right would attest), I’ve been covering the twisted path various CETP programs have traversed, from Phase I to. . . today’s new. Pfizer, Lilly, Roche and Merck all have seen varying disappointments — over the last decade — and some moderate successes. [Last Spring’s backgrounder, on Lilly’s travails.]

True enough, today’s real world outcomes data (the gold standard — i.e., a statistically significant number of fewer CV events) is measured only against the performance of a placebo (in patients already on a cholesterol medication) — but the drug’s effect is thus certainly. . . real. From the press release then:

. . . .[Merck announced that] the REVEAL outcomes study of anacetrapib met its primary endpoint, significantly reducing major coronary events compared to placebo in patients at risk for cardiac events who are already receiving an effective LDL-C lowering regimen. The safety profile of anacetrapib in the early analysis was generally consistent with that demonstrated in previous studies of the drug, including accumulation of anacetrapib in adipose tissue. . . .


Merck plans to review the results of the trial with external experts, and will consider whether to file new drug applications with the U.S. FDA and other regulatory agencies. . . .

It is still not entirely certain that Merck will seek FDA approval, given the above mentioned accumulation issue — but it is decidedly good news for Kenilworth — and likely for the whole CETP class of candidates. We still expect no US commercial launch until late in Q1 2018. 

Onward, on a locally gorgeous second Shkreli-hilarity laced jury selection morning — just getting started, now in the US District courthouse’s largest ceremonial courtroom, over in Brooklyn. Smile.

नमस्ते

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