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

Jardiance Mortality Claim Narrowly Endorsed By FDA Advisory Committee

This article was originally published in The Pink Sheet Daily

Executive Summary

The 12-11 vote supporting new indication for reduced incidence of cardiovascular death provides cover for FDA if it decides more data are needed before granting first CV benefit claim to a diabetes drug.

You may also be interested in...



Boehringer's Empagliflozin Heads To Advisory Cmte. With Questions On Treatment Effect

Boehringer wants supplemental empagliflozin claim as insulin adjunct to improve glycemic control in type 1 diabetes, but US FDA questions the size of the clinical benefit and the magnitude of a diabetic ketoacidosis risk.

US FDA May Change Requirements For CV Outcomes Trials For Type 2 Diabetes Drugs

Endocrinologic and Metabolic Drugs Advisory Committee will reconsider 2008 guidance on evaluating CV risks in antidiabetic therapies at two-day meeting in October.

Victoza’s Non-Cardio Safety May Dominate At FDA Panel Review

US FDA does not raise any major concerns about study’s design or results to support cardiovascular risk reduction claim for Novo Nordisk’s GLP-1 agonist liraglutide ahead of advisory committee, but agency gives close scrutiny to non-CV safety events of interest.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS079557

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