Merck’s Boceprevir To Run Into A Wrinkle At FDA Advisory Panel?


It seems that the FDA Advisory Panel is concerned about the legacy Schering-Plough candidate’s side effect profile. The preliminary drafts of agenda, and questions have been released by the FDA, this morning. And here’s the first question: “. . . .1. Please comment on the safety of boceprevir in patients with chronic hepatitis C genotype 1, focusing mainly on the hematological effects of boceprevir in combination with pegylated interferon and ribavirin. . . .” In plain(er) English, that question asks about anemeia — and the rates of the same, as seen in some of those patients, on the boceprevir combination therapy.

This, per Reuters reporting:

. . . .A main issue for discussion is the increase in anemia in patients treated with boceprevir, Food and Drug Administration staff said in a summary prepared for an advisory panel that will review the drug on Wednesday.

Another “potential safety signal” is a higher number of patients who reported psychiatric symptoms such as suicidal and homicidal thoughts, the FDA reviewers said. But they added it was “difficult to make any meaningful clinical conclusions” about the cases.

FDA staff said they generally agreed with Merck’s assessment that boceprevir was effective in treating hepatitis C, a disease that destroys the liver. . . .

The 26th and 27 th will be big days for Merck and Vertex — but proportionately bigger for Vertex, relative to its overall size. Vertex expects taht its Telaprevir will come through the panel with flying colors. We’ll keep a weather eye on it all — in fact, we’ll watch the live webcast from FDA’s website — and you can too, by clicking that link on the morning of the 27th (Adobe Connect required).

Vertex’s analogous materials should be available tomorrow morning at the FDA’s web-window.

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