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

Edoxaban Review ‘Not About Comparative Efficacy,’ FDA Says

Executive Summary

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.

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.

Abuse-Deterrent Opioids Could Gain Significant First-Mover Advantage Under FDA Guidance

FDA recommends head-to-head studies against already marketed products – an unusual development policy for the agency.

FDA Approves Daiichi’s Savaysa, But Not For AF Patients With Normal Kidney Function

The Japanese pharma scored an approval of its oral anticoagulant, but is at a disadvantage to competition due to a label that restricts use to patients with renal impairment.

Related Content

Topics

Related Companies

Latest News
UsernamePublicRestriction

Register

PS056473

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