Anti-NGF Studies Face Major Redesign After Arthritis Advisory Cmte. Urges Resumed Testing
This article was originally published in The Pink Sheet Daily
Pfizer’s tanezumab, Regeneron’s REGN475 and Janssen’s fulranumab could head back to the clinic soon, but will need radical protocol changes to protect patients from the emerging risk of joint destruction.
You may also be interested in...
Pfizer’s Tanezumab REMS Faces US FDA Doubts Heading Into Panel Review
Measures aimed at mitigating risk of progressive joint damage with the first-in-class nerve growth factor inhibitor may not be clinically feasible to implement or prevent rapid progression of osteoarthritis, FDA reviewers say; agency briefing document describes efficacy as 'modest' and says the sponsor's patient preference study was flawed and 'uninformative.'
Anti-NGF Drugs Clinical Holds Could Depend On What FDA Panel Thinks Of Standard Of Care
FDA’s Arthritis Advisory Committee will review troubling reports that the drugs, meant to relieve chronic pain from osteoarthritis and other diseases, may also destroy patients’ joints.
Janssen’s Sirturo Needs Minor Tweaks To Confirmatory Trial, FDA Panel Says
Gathering more data to assuage concerns about possibly lower efficacy in black patients will be key to converting the accelerated approval to full approval for the tuberculosis drug, FDA’s Anti-Infective Drugs Advisory Committee concludes.