We agree with the FDA’s assessment that the risk mitigation measures proposed for tanezumab are not likely to be feasible or effective, and there are serious risks, even after patients discontinue use.
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March 24, 2021
Thank you for the opportunity to speak today on behalf of the National Center for Health Research. I am Dr. Meg Seymour, a senior fellow at the center. We analyze scientific data to provide objective health information to patients, health professionals, and policy makers. We do not accept funding from drug or medical device companies, so I have no conflicts of interest.
A major question is whether tanezumab is safe and effective to treat moderate to severe osteoarthritis when other treatments are ineffective or inappropriate. Unfortunately, there is no convincing evidence that this drug is more effective than NSAIDs, and there are no data directly comparing its risks or benefits to opioids.
However, there are serious risks, even after patients discontinue use. We agree with FDA scientists that this drug’s safety profile is not comparable to NSAIDs or opioids.
Let’s look at the data on Rapidly Progressing Osteoarthritis (RPOA). The severity was categorized into 2 groups, RPOA1 and RPOA2. RPOA1 was 2 to 4 times higher in patients treated with the drug compared with patients treated with NSAIDs. Worse yet, 15% of those who developed RPOA1 and 60% of those who developed RPOA2 ended up needing total joint replacement surgery. In fact, patients taking this drug were 2-3 times as likely to need joint replacement as patients taking NSAIDS. This should be unacceptable, especially since there is also evidence that joints may continue to deteriorate even after the drug is discontinued, and that RPOA can occur in joints that were healthy prior to treatment with the drug.
You are asked whether the proposed REMS protocol will ensure that the benefits outweigh the risks. We agree with the FDA assessment that the proposed REMS measures are not feasible and that there are no data to support them. Do you think these mitigation strategies would be replicated in most clinical practices?
I respectfully ask you to consider how “real world” use of the drug would affect patient outcomes, if the drug were approved. For example, several studies excluded patients at a risk of cardiovascular events, such as those with cardiovascular disease (CVD). Since both joint pain and CVD are associated with being overweight, how realistic is it to assume that this drug would not be prescribed to patients with cardiovascular risks? Also, is it realistic to assume that patients will not use this drug while also taking NSAIDs, which would double or triple their risk of joints being severely damaged by RPOA.
Another shortcoming of the data is the lack of information about safety when used for more than one year. Pain medication for osteoarthritis tends to be taken for years, not months.
The bottom line is that we agree with the FDA’s assessment that the risk mitigation measures proposed are not likely to be feasible or effective. When you vote tomorrow, we urge you to focus on the lack of proven safety and effectiveness in the clinical trials, as well as higher risks when used in the real-world.
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