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

Tale Of Two Adcomms: US FDA Handling Of Entresto Data May Have Helped Avoid Aducanumab’s Fate

Executive Summary

Review divisions strongly encouraged filing of both the Novartis and Biogen drugs despite trials that missed their primary endpoints; with the heart failure drug, the agency took a more even-handed approach to presenting the data and was commended for its willingness to look beyond the narrowly missed p-value, in contrast to the barrage of criticism it faced with the Alzheimer’s drug.

You may also be interested in...



Novartis’ Entresto Gains US FDA Panel Nod For New Heart Failure Claim

But advisory committee members debate how to define the target population for a new indication, shying away from use of ‘preserved’ to characterize heart failure patients with ejection fraction levels below normal but greater than the definition of ‘reduced’ EF.

Spironolactone Starts Out On ‘Unusual But Not Unprecedented’ Regulatory Path, Thanks To US FDA Reviewers

Despite the lack of a sponsor or an application, FDA’s cardio-renal advisory committee will consider a possible new indication for the generically available drug in heart failure with preserved ejection fraction (HFpEF), driven by agency analysis of the NIH-sponsored TOPCAT trial.

What Did US FDA Do Wrong In Its Review Of Aducanumab? AdCom Members Have A List

Committee members rebuked FDA for its positive review of Biogen’s Alzheimer’s disease drug, objecting to its ‘terrifically one-sided’ analysis of data, the short shrift given the contrary conclusions of its own statistician, and its interpretation of a dosing study to support the sole positive Phase III study.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS143482

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