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

Intercept’s NASH Drug Delayed By April Advisory Committee

Executive Summary

US FDA sets 22 April for advisory committee review of obeticholic acid in NASH, though whether the extended review was due to scheduling issues or any questions about Intercept's application itself remain unclear.

You may also be interested in...



Keeping Track: Vascepa Adds CV Risk Reduction Claim And Submissions Pour Into FDA

The latest drug development news and highlights from our US FDA Performance Tracker.

Intercept Says Data Indicate Pruritus Worries In NASH Could Be Overstated

Patient-reported outcomes indicate patients don’t see itch as a major quality-of-life factor. Intercept also reports that adding earlier-stage patients to review of OCA shows better data on resolving NASH.

Will A US FDA Advisory Committee Be In Intercept's Future?

There are strong reasons to justify an advisory committee meeting for the NASH application, but also an outlet for the US FDA to skip it.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS141382

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