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

 
• By Sue Sutter

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 tanezumab’s benefits outweigh its risks in osteoarthritis patients for...

Advisory Committee Vote
  • Will the REMS proposed by the applicant ensure that the benefits of tanezumab outweigh its risks? Y – 1, N – 19

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