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

Use Of Pre-Approval CV Data From Ongoing Trial Gets Once-Over At Canagliflozin Panel

Executive Summary

There is no statistical reason not to allow a single trial to provide pre-approval and post-approval cardiovascular hazard ratios for a diabetes drug, FDA says, but Janssen’s canagliflozin would be the first. The Endocrinologic and Metabolic Drugs Advisory Committee backed approval 10-5.

You may also be interested in...



FDA’s Parks Expands REMS Portfolio With Move To ODE II Deputy Slot

Currently the head of the Division of Metabolic and Endocrinology Products, Parks has handled drug safety controversies in diabetes and obesity products.

J&J Gains FDA OK For First-In-Class Type 2 Diabetes Drug Invokana

J&J is the first pharma company to bring an SGLT2 inhibitor to market, but its window of exclusivity in that class may be narrow, given that FDA is slated to assess two other SGLT2s later this year.

2013 Diabetes NMEs Span Classes, But Safety Is A Review Issue For All

The repercussions of FDA’s 2008 guidance on cardiovascular risk evaluation in diabetes trials are still being felt in reviews of new agents. CV concerns earned Novo Nordisk’s long-acting basal insulin a “complete response” letter. Pending applications include two GLP-1 agonists and a possible first-in-class SGLT-2 inhibitor, and safety is a major review issue for all of them.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

LL005491

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