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

Will CV Verdicts For Onglyza, Nesina Cause FDA To Change Its Tune On Antidiabetic Safety?

Executive Summary

Large outcomes studies showed neither cardiovascular harm nor benefit with BMS/AstraZeneca’s saxagliptin or Takeda’s alogliptin, prompting some commenters to question whether FDA’s blanket approach to CV safety for all antidiabetic agents needs adjustment.

You may also be interested in...



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.

Diabetes Trials Could Include Hypoglycemia As Patient-Reported Outcome

FDA, industry and patient advocates all want studies to move beyond HbA1c, but still need to develop common thresholds and definitions to support patient-reported outcomes in diabetes drug development.

Diabetes Drug Safety Might Be Best Assessed With Real-World Data

Meta-analysis published in JAMA suggests registry-based studies could be alternative to large cardiovascular outcomes trials.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS055587

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