WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) should not approve Pfizer’s tanezumab for treatment of osteoarthritis because studies show the drug fails to provide meaningful relief of arthritis symptoms but does cause a dramatic increase in the rates of serious joint damage and of total joint replacements, Michael Carome, director of Public Citizen’s Health Research Group will say in testimony tomorrow.
On Mar. 10, Public Citizen submitted comments to the agency’s Arthritis Advisory Committee (AAC) and Drug Safety and Risk Management Advisory (DSaRMAC) Committee opposing approval of tanezumab. Carome released the following statement ahead of the joint meeting:
“The FDA’s pending decision regarding tanezumab should not even be a close call.
“Two short-term studies comparing tanezumab to placebo showed that the drug provided only minimal improvement in pain and other symptoms in osteoarthritis patients for whom the drug is intended and increased the risk of severe joint damage with as little as two doses of the drug given eight weeks apart.
“A long-term study involving nearly 3,000 osteoarthritis patients compared tanezumab injected every 8 weeks for a year to daily use of widely prescribed oral anti-inflammatory drugs like naproxen (Aleve). This study showed that tanezumab was no better than naproxen and similar drugs in relieving osteoarthritis symptoms but did cause a dramatic increase in the rates of serious joint damage and of total joint replacements. And such joint damage may occur even after the drug is stopped.
“The fact that tanezumab causes an unacceptable rate of severe joint damage was recognized by the FDA back in 2010 and resulted in a years-long suspension of clinical trials of the drug. In 2012, we testified before the Arthritis Advisory Committee and urged that the testing of tanezumab and similar drugs in patients be permanently halted, but unfortunately, the committee and the FDA concluded that further research with the drug should be allowed. The data from the three studies to be considered by the AAC and DSaRMAC tomorrow demonstrates how misguided and reckless that conclusion was.
“A drug like tanezumab that accelerates the joint destruction of the underlying osteoarthritis disease it is intended to treat but lacks any evidence of clinically meaningful benefit in comparison to use of a placebo or oral NSAIDs obviously should never be approved by the FDA. It is baffling why the FDA felt it needed to bring the application for this drug before the advisory committees.
“Moreover, any further human studies of the tanezumab would also be unethical.”