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

Xarelto Tested FDA’s Comparative Efficacy Powers, But Conservative View Prevailed

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

J&J/Bayer’s Xarelto tested the limits of FDA’s policy on comparative efficacy, thanks to suboptimal use of the active comparator, warfarin, and the introduction of a new competitor, Pradaxa. In the medical reviewers’ view, new therapies should be as effective as existing therapies used skillfully, but division leadership would withhold approval only if the new drug were clearly inferior to approved agents.

You may also be interested in...



Savaysa Shows The Good And Bad Of Being Late In Class

As Daiichi’s experience suggests, sponsors of later-in-class products may face unfavorable efficacy comparisons to their earlier-approved brethren and challenges in qualifying for a priority review; however, risk management obligations may be less burdensome than for first-in-class products.

Edoxaban Review ‘Not About Comparative Efficacy,’ FDA Says

Structured benefit/risk framework requires consideration of current treatment options, agency says in asking its cardio-renal advisory committee to consider the existence of three other novel anticoagulants when weighing the poor efficacy seen with Daiichi’s Factor Xa inhibitor in a large patient subgroup.

FDA “Available Therapy” Determination Is A Moving Target, Industry Groups Say

In comments on the agency’s expedited programs draft guidance, PhRMA and BIO say a decision about the relevant standard of care is needed earlier in the development process; groups call for more flexibility on accelerated approval than is suggested in the guidance and identify several issues involving breakthrough therapies that need more clarity.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS005090

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