Anti-NGF Studies Face Major Redesign After Arthritis Advisory Cmte. Urges Resumed Testing

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.

FDA and the sponsors of anti-nerve growth factor drugs now face the challenge of redesigning clinical trials for the experimental agents after the agency’s Arthritis Advisory Committee urged that the studies be resumed at a March 12 meeting.

The committee felt that the trials – which FDA placed on clinical hold when some patients experienced accelerated joint destruction...

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