Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Gilead's Epclusa: FDA Sought To Push Efficacy Bar Higher In Hepatitis C

Executive Summary

Drug Review Profile of the pan-genotypic HCV treatment shows agency staff debating whether fixed-dose combination's strong efficacy in certain genotype 3 patients could be further maximized by adding ribavirin.

You may also be interested in...



Drug Review Profiles: Behind The Scenes At US FDA

A year in our long-running series of deep dives into FDA review documents.

US FDA's Search For Meaning: Interpretation Of Regulatory Language Can Inspire Conflict In Drug Reviews

The Pink Sheet's Drug Review Profile series illustrates the challenge of reconciling review realities and broad statutory directives.

Harvoni Approval Led To Narrowing Of Epclusa's Breakthrough Status

US FDA cited strong efficacy, good safety of Gilead's Harvoni and AbbVie's Viekira Pak in rescinding breakthrough therapy designation for the sofosbuvir/velpatasvir fixed-dose combination in hepatitis C patients with genotype 1 infection.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

ID005817

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel