Anti-NGFs Advisory Committee Postponed As FDA Reviews New Information
This article was originally published in The Pink Sheet Daily
Executive SummaryThe agency is assessing safety signals for the biologics, which are being developed for chronic pain.
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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.