Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Intercept Withdraws EU NASH Drug Filing But May Retry

Executive Summary

New data that is being collected to support a US resubmission for Intercept’s obeticholic acid might also be used to support a resubmission to the European Medicines Agency.

You may also be interested in...



EMA Considers Accelerated Review Of Madrigal’s NASH Drug Filing, Discloses Other Fast-Track Decisions

Resmetirom, for noncirrhotic non-alcoholic steatohepatitis, is among the investigational products that the European Medicines Agency has been considering for review under its accelerated assessment pathway.

EU Crunch Time For 15 New Drugs At Final CHMP Meeting Of 2021

Drugs for COVID-19, Alzheimer’s disease and heavy menstrual bleeding due to uterine fibroids are among the latest products that are this week being considered for marketing approval by the European Medicine Agency’s human drugs evaluation committee, the CHMP.

Intercept Plans To Refile OCA For NASH At US FDA With Consensus Reads Of Patient Biopsies

Additional patients and more long-term data could also help make case for obeticholic acid. Intercept hopes to complete its review of the pivotal REGENERATE trial during H1 2022.

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS145383

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