No Relief For Pfizer As It Shuts Down Additional Tanezumab Trials
This article was originally published in The Pink Sheet Daily
Safety concerns require Pfizer to scupper two additional studies of its Phase III tanezumab, casting doubt on an entire class of new pain drugs.
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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.
FDA sets March 12 as date for the Arthritis Advisory Committee to weigh in on whether safety issues are a barrier to development of anti-NGF compounds as analgesics. Developers’ trials are on hold while FDA considers the potential for adverse effects seen in osteoarthritis patients taking the monoclonal antibodies for pain.
The entire class of biologics has fallen under suspicion of worsening the very condition it is supposed to treat, and FDA has imposed clinical holds on ongoing trials.