FDA panel rejects Pfizer arthritis drug as too risky

Pharmacist.com - 8/12/2021

An FDA advisory panel recommended Thursday, in a vote of 19-1, against approving Pfizer's experimental drug for the treatment of mild to moderate knee and hip pain. Experts on the committee pointed out that injectable tanezumab was no more effective than common NSAID treatments for arthritis, such as naproxen (Aleve—Bayer) and celecoxib (Celebrex—Pfizer), but carried risks that could not be overlooked. Results from studies showed that tanezumab may result in damage to healthy joints, swelling or nerve damage, or accelerated joint damage possibly leading to knee or hip replacement—risks that outweigh the benefits of the drug. FDA is not required to follow recommendations or advice from its outside experts, but usually does. Pfizer, which has been developing the arthritis drug for 15 years, expressed disappointment but indicated that it will work with FDA on next steps.

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