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

Vanlev in refractory patients

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Bristol-Myers Squibb could seek approval of Vanlev (omapatrilat) through a study demonstrating a benefit in patients who have persistent serious hypertension after treatment with drugs from three different antihypertensive classes, FDA's Cardiovascular & Renal Drugs Advisory Committee suggests at its July 19 meeting. The committee voted five to one against approval because of concerns that benefits shown over enalapril (a 3.2 mm Hg greater reduction in systolic blood pressure and a 1.9 mm Hg greater reduction in diastolic BP in the OCTAVE trial) do not outweigh the risk of angioedema (2.17% for omapatrilat vs. 0.68% for enalapril

You may also be interested in...



Exec Chat: How Edwards Lifesciences Deploys AI, Remote Monitoring To Help Doctors Make Life-Critical Decisions

Edwards Lifesciences’ head of critical care expects that “smart recovery” AI-driven products will grow the fastest in its critical care unit, which is expected to reach $800m in total revenues for 2021.

Cara Placing Korsuva Hopes On Oral Formulation, Broad Pruritis Label

I.V. Korsuva now has an August FDA action date, which partner Vifor would commercialize in the ESRD dialysis setting while Cara works toward a broad anti-pruritus label for its oral tablet formulation.

‘Reckless’ State Campaigns Seek To Undermine Western COVID-19 Vaccines

China, Iran and especially Russia have launched campaigns aimed at undermining confidence in Western vaccines, especially Pfizer’s, according to two reports.

Topics

UsernamePublicRestriction

Register

OM010563

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