In Vivo 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


Aspirin submission

This article was originally published in The Tan Sheet

Executive Summary

Aspirin "appears to be a significant player in the reduction in the incidence of CHD events and non-fatal myocardial infarction," according to a recent submission to FDA. Al Bartolucci, PhD, University of Alabama, et al., conducted a meta-analysis of the six major clinical trials on use of aspirin for primary prevention of heart attack, including the Women's Health Study. The researchers used data provided by the U.S. Preventive Services Task Force, finding that aspirin reduces incidence of cardiovascular events defined as a composite of CV deaths, MI and stroke. The drug had "no significant effect on stroke, fatal CHD or all-cause mortality," Bartolucci et al. add. The submission references Bayer's citizen petition submitted in 2003 seeking an indication on aspirin professional labeling for primary prevention of MI. Bartolucci et al. say their analysis is shorter version of a full-length manuscript they will submit to FDA in the future...

You may also be interested in...

Keeping Track: US FDA Clears Esperion’s Nexletol, Baudax’ Anjeso, Agile’s Twirla

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.

Esperion’s Nexletol Reaches The Cholesterol Market Priced To Sell

Esperion obtained an on-time approval of Nexletol (bempedoic acid) for a pair of LDL cholesterol-lowering indications on 21 February. 

Pharmacogenetic Tests: US FDA Tries Off-Label Approach To Guide Consumers

US FDA’s latest effort to provide guidance for consumers on pharmacogenomics tests underscores the challenges the agency faces in the absence of a clear regulatory framework for lab-developed tests – and with no easy mechanism to update labels for off-patent drugs.





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