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.

shutterstock 18043132  Hawaii - Oct. 24: A surfboard explodes beneath surfer Ezra Sitt's feet when he hits the lip of the wave Oct.24, 2007 at Rocky Point, Hawaii. This is a great example of a freak accident while surfing.  M By Mana Photo
Tanezumab wiped out at its advisory committee meeting for use in osteoarthritis.

Absent long-term data on the safety of Pfizer Inc.’s tanezumab and the prognosis of osteoarthritis patients who suffer joint damage and discontinue the nerve growth factor inhibitor, there is no amount of tinkering with a proposed Risk Evaluation and Mitigation Strategy that would result in a positive benefit-risk profile, US Food and Drug Administration advisory committee members said on 25 March.

In a lopsided vote, the arthritis and drug safety/risk management advisory committees said Pfizer’s proposed REMS would not ensure that...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from US FDA Performance Tracker

More from Regulatory Trackers

EU CHMP Opinions And MAA Updates

 

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

EU Authorization Before US? Biologics Manufacturing Is Likely To Blame

 

In the infrequent cases when EU authorization precedes US FDA approvals of new products, biologics manufacturing issues are usually to blame, a Pink Sheet analysis found.

Global Pharma Guidance Tracker - April 2025

 

Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.