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
Advisory Committee Vote
- Will the REMS proposed by the applicant ensure that the benefits of tanezumab
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