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

 
• By Sue Sutter

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.

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Osteoarthritis patients in Pfizer's study said they were more willing to risk joint damage than dependence on opioids. • Source: Shutterstock

Pfizer Inc.’s unsuccessful attempt to use patient preference information (PPI) to sway the US Food and Drug Administration’s view on tanezumab should be a lesson for other sponsors on appropriate study design, particularly when an investigational product has a challenging benefit-risk profile.

Pfizer offered results from a preference study showing patients with moderate to severe osteoarthritis are willing to risk some level of joint damage in exchange for improved symptom control

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US FDA’s Review Performance Held Steady Despite Stormy First Quarter

 
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US FDA’s Review Performance Held Steady Despite Stormy First Quarter

 
• By Bridget Silverman

Organizational turmoil has not yet affected reviews of novel agent applications, with Q1 2025 approvals coming in low, but the first quarter share of the entire year is variable.