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

Brinavess' US Review: EU Postmarket Data Unlikely To Save Troubled AFib Drug

Executive Summary

Correvio's atrial fibrillation drug Brinavess will return to a US FDA advisory committee more than a decade after the agency first declined to approve the drug;  FDA still has a series of cardiovascular safety concerns related to the drug and is not convinced by data from the European experience.

You may also be interested in...



Keeping Track Of The US FDA's Final Novel Approvals, CRLs Of 2019

The latest news on novel drug approvals and complete response letters from our US FDA Performance Tracker.

Real-World Evidence Fails Another Test At US FDA

Correvio’s attempt to move vernakalant from 'clinical hold' to 'FDA approved' was a huge long shot. But the advisory committee vote – and looming FDA rejection – are another indication that real-world data is not a panacea.

Keeping Track: US FDA Closes Out First Half Of 2019 With CRL For Edsivo, But A Burst Of Supplemental Approvals

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

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS141324

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