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

GSK Coreg adds mortality claim

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Revised labeling for GlaxoSmithKline's Coreg (carvedilol) cites a 23% risk reduction in all-cause mortality for myocardial infarction patients. FDA approved the beta blocker March 27 for reducing cardiovascular mortality in clinically stable post-MI patients with left ventricular dysfunction. The sNDA was based on GSK's 1,959-patient CAPRICORN study, in which all-cause mortality was 15% for placebo and 12% for Coreg (p=0.03). Labeling does not mention that results did not meet the pre-specified p-value of .004 for statistical significance; FDA's Cardiovascular & Renal Drugs Advisory Committee voted Jan. 7 that other Coreg studies and experience with other beta blockers supported the indication. GSK is promoting Coreg as "the only beta-blocking agent approved to reduce the risk of death in mild, moderate and severe heart failure
Advertisement

Topics

Advertisement
UsernamePublicRestriction

Register

PS002212

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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