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

Patient Preference Data: Pfizer’s Tanezumab Study Had ‘Flaws’ That Made It ‘Uninformative’

Executive Summary

Study showed osteoarthritis patients are more willing to accept risk of joint damage with NGF-inhibitors than dependency associated with opioids, Pfizer said; however, FDA highlighted key flaws in study design, sample population and survey content.

You may also be interested in...



Pfizer’s Tanezumab REMS Cannot Make Benefit-Risk Positive, US FDA Panel Says

Panelists say REMS would need data on long-term safety and progression of joint damage after discontinuation. In 19-1 vote, advisory committee concludes proposed Risk Evaluation and Mitigation Strategy will not ensure the anti-nerve growth factor’s modest benefits outweigh risks of joint destruction in osteoarthritis patients.

Pfizer’s Tanezumab REMS Faces US FDA Doubts Heading Into Panel Review

Measures aimed at mitigating risk of progressive joint damage with the first-in-class nerve growth factor inhibitor may not be clinically feasible to implement or prevent rapid progression of osteoarthritis, FDA reviewers say; agency briefing document describes efficacy as 'modest' and says the sponsor's patient preference study was flawed and 'uninformative.'

Patient-Focused Drug Development, Complex Trial Design May Not Get More Funding In PDUFA VII

US FDA proposed increasing staffing and resources for both programs during the next user fee program cycle, but industry representatives did not believe it necessary.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS144073

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