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

Cangrelor’s Approval Prospects: FDA Reviewers Say Yes, Team Leader Says No

This article was originally published in The Pink Sheet Daily

Executive Summary

As The Medicines Co.’s anticlotting drug heads to the Cardiovascular and Renal Drugs Advisory Committee, questions about comparator dosing and timing and the severity of bleeding events will be on the agenda.

You may also be interested in...



Cangrelor’s Second Advisory Committee Could Be The Charm

FDA reviewers again recommended approval of the antiplatelet, but this time there doesn’t appear to be opposition from the team leader.

FDA’s Cangrelor “Complete Response” Leaves Room For Approval Without New Trial

Agency requests additional analyses, but not a new study, supporting the antiplatelet’s use in patients undergoing percutaneous coronary intervention, The Medicines Co. says. However, a second indication in stent thrombosis patients who must stop oral antiplatelet therapy would require a new outcomes trial.

TMC Still Optimistic About Cangrelor Approval Despite Negative Opinion

The Medicines Company seemed positive about the prospects for approval of its anti-clotting drug, even though an advisory committee voted against approval just a week ago.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS122308

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