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

Epclusa Clinical Development Timeline

Executive Summary

Chronicle of the development and FDA review of Gilead’s fixed-dose combination of sofosbuvir and velpatasvir for hepatitis C.

You may also be interested in...



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

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.

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.

Epclusa Reviewers

FDA staff who participated in the review of Gilead’s pan-genotypic hepatitis C drug.

Topics

UsernamePublicRestriction

Register

ID1132090

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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