Tuesday, June 27, 2017

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 news. 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.



Anonymous said...

I suspect that the adipose accumulation issue is a big concern for the FDA and that they are likely to ask MRK for long-term follow-up data on outcomes for these patients.

condor said...

[Reposting, sans typos -- hopefully!]

Thank you so much Anon. (and welcome back!) --

I think you're exactly right -- and that explains the real dilemma, about whether to file for approval at all.

Some pharma biz talking heads (in the MSM outlets) have recently been video interviewed/written to the effect that Merck will almost certainly file, because "it costs nothing (more)" to file the NDA. Uh-Huh.

I on the other hand, like you, know that Kenilworth is weighing the cost of the longitudinal studies -- and the liability profile (should a long-acting but more-severe off-target effect emerge, like strokes, for example) -- against any deeper into the future net revenue stream, from an FDA approved jacket.

We shall see. But great comment! Do stop back. . .

Namaste. . . .