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Post Panels, Telaprevir And Boceprevir Now Face FDA's Risk Management Review

Executive Summary

Coming out of FDA’s Antiviral Drugs Advisory Committee reviews with ringing endorsement for both Vertex Pharmaceuticals’ telaprevir and Merck’s boceprevir, the attention now shifts to risk management for the anemia associated with both protease inhibitors for hepatitis C and for rash associated with telaprevir.

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Incivek Black Box Creates Fallout Risk For Vertex, FDA On Rash-related Fatalities

For Vertex, the key question is how much is physician and patient concern about the adverse events is already reflected in the softening sales of the hepatitis C drug; for FDA, the question is how effective will label-based risk management be.

Telaprevir Labeling Advantages Should Offset Higher Price In Hepatitis C Battle

Vertex Pharmaceuticals' Incivek (telaprevir) has cleared FDA with labeling advantages that should enable it to win a majority of patients in the battle against Merck's competing protease inhibitor for hepatitis C, Victrelis (boceprevir).

Telaprevir Labeling Advantages Should Offset Higher Price In Hepatitis C Battle

Vertex Pharmaceuticals' Incivek (telaprevir) has cleared FDA with labeling advantages that should enable it to win a majority of patients in the battle against Merck's competing protease inhibitor for hepatitis C, Victrelis (boceprevir).

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