1. Pink Sheet
  2. >>Geography
  3. >>North America
  4. >>United States

Merck’s HCV Combo Will Test FDA’s ‘Breakthrough’ Rescission Process

 
• By Sue Sutter

Agency cites availability of other recently approved therapies in notifying Merck of intent to rescind the designation for grazoprevir/elbasvir in hepatitis C. Sponsor will seek a meeting with FDA to make its case for retaining breakthrough status.

Merck & Co. Inc. will be the first “breakthrough therapy” sponsor to publicly test FDA’s process for withdrawing the coveted status, having heard from the agency that it no longer thinks Merck’s hepatitis C drugs qualify for the designation.

The recent approval of several highly effective treatments for chronic hepatitis C has endangered Merck’s designation for its two-drug treatment of HCV patients with genotype 1 infection.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from United States

More from North America