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FDA Advisers Urge Lifting Clinical Hold on Pain-Treating NGF Inhibitors
An FDA advisory panel has unanimously recommended lifting a clinical hold on anti-nerve growth factor (anti-NGF) drugs, but one panelist says three sponsors of stalled trials should start over because of inadequate data on the drugs’ risks. The FDA’s Arthritis Drugs Advisory Committee voted 21–0 March 12 to urge resumption of the trials, pointing to a great need for a new analgesic therapy in the osteoarthritis (OA) arena. But panelists uniformly urged caution in allowing them to move forward, saying safety concerns are significant enough to warrant additional safeguards.
Washington Drug Letter |
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