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Author Topic: FDA To Yank ‘Breakthrough’ Status for Merck's New Hep C Drug  (Read 7174 times)

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Offline Hep Editors

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    • Hep Mag
FDA To Yank ‘Breakthrough’ Status for Merck's New Hep C Drug
« on: February 04, 2015, 12:48:16 pm »
Apparently, Merck's late-stage player in the hep C game doesn't look quite as "revolutionary" to the FDA as it once did.

Merck’s upcoming fixed-dose tablet includes the investigational NS3/4A protease inhibitor grazoprevir and the investigational NS5A replication complex inhibitor elbasvir, to be taken once a day.

The drugmaker says it is still going to seek approval for the new treatment in the first half of 2015. However, the FDA's move may start slowing the timeline for new hep C therapies.

Read more: http://www.hepmag.com/articles/breakthrough_rescind_merck_2501_26762.shtml


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