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

Olysio Pre-treatment Screening Cleared Way For FDA Nod In Partial And Null Responders

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA reviewers were willing to extend simeprevir’s use to HCV patients who had failed prior pegylated interferon/ribavirin therapy but only if labeling contained a strong recommendation for pre-treatment screening to detect the Q80K polymorphism, which was associated with reduced efficacy.

Advertisement
Advertisement

Related Content

Topics

Related Companies

Advertisement
UsernamePublicRestriction

Register

PS005723

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