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

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

This article was originally published in The Pink Sheet Daily

Executive Summary

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.

You may also be interested in...



Cangrelor Advisory Cmte. Unsure Whether Plavix Even Needs Replacing

After a brutal panel review, The Medicines Co.’s best chance for its anti-clotting medication may be to create a “better sense of the unmet need” in the perioperative setting when Plavix use must be suspended.

Cangrelor Can’t Escape Its Past At FDA Advisory Committee

The Medicines Co.’s anti-clotting drug had one relatively positive study, but two failed ones, and that produced two lopsided “no” votes by the Cardiovascular and Renal Drugs Advisory Committee.

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

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.

Topics

Related Companies

UsernamePublicRestriction

Register

LL111799

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