Anti-NGF Drugs Clinical Holds Could Depend On What FDA Panel Thinks Of Standard Of Care
This article was originally published in The Pink Sheet Daily
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.
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FDA’s Arthritis Advisory Committee suggests strictures that could be so strong as to discourage the resumption of clinical trials of Pfizer’s tanezumab, Regeneron’s REGN475 and Janssen’s fulranumab.
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.
The agency is assessing safety signals for the biologics, which are being developed for chronic pain.