Pfizer’s Tanezumab REMS Cannot Make Benefit-Risk Positive, US FDA Panel Says
Executive Summary
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.
You may also be interested in...
Do Patients Understand The Term ‘Median’ In Advertising? US FDA Aims To Find Out
In first Rx advertising research project of 2023, FDA will survey consumers on how they interpret quantitative claims in DTC ads. Lilly questions design of another study examining relative importance of product information, citing FDA comments at tanezumab advisory committee.
Pfizer/Lilly Discontinue Tanezumab, The Likely End For A Class Dogged By Safety
The nerve growth factor inhibitor for osteoarthritis pain is one of the last still in development after safety largely sidetracked the class of drugs.
BeiGene’s Brukinsa Among Nine Drugs To Win EU Marketing Thumbs Up
A number of new medicines are moving closer to the EU market after the European Medicines Agency recommended in favor of their approval.