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

Birth Of A Biomarker? FDA Doesn't Define Eosinophilic Asthma, Defers To Docs On Nucala

Executive Summary

FDA declined to codify new asthma phenotype in the indication for GSK's Nucala, leaving emerging definition of eosinophilic asthma to the medical community. For FDA's endorsement, it is not enough to show that patients with eosinophilia biomarkers benefit; you also need to show that patients without the biomarker do not benefit.

You may also be interested in...



US FDA Rejection Stings Nucala In COPD; New Study May Be Needed

Mepolizumab would be first drug for chronic obstructive pulmonary disorder to use eosinophil count as a biomarker, but FDA’s complete response letter says more clinical data are needed.

Did GSK's Nucala Trials In COPD Strengthen Confidence In The Eosinophil Biomarker?

US FDA was hoping Pulmonary-Allergy Drugs Advisory Committee could help provide some clarity on its use, but there still are many questions.

GSK's Nucala For COPD Needs Better-Defined Patient Population, US FDA Panel Says

Unclear data on monoclonal antibody's efficacy caused many members of Pulmonary-Allergy Drugs Advisory Committee to vote against recommending approval.

Related Content

Topics

Related Companies

Latest News
UsernamePublicRestriction

Register

PS057525

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