U.S. health advisers on Thursday sharply criticized the experimental arthritis drug, saying it was too risky, even with restrictions on its use.
The Board of Experts of the Food and Drug Administration confirmed by a vote of 19-1 that the modest benefits of the drug do not outweigh its significant risks, even with the means offered to limit the number of people receiving medication. Pfizer is seeking FDA approval for a drug called tanezumab to treat mild pain in the thighs, knees and joints. It is given by injection every two months.
A small percentage of participants in the study found that joint damage worsened more rapidly, sometimes requiring hip or knee replacement. Others had a tumor or a nerve injury. Some have damaged healthy joints.
“I’m concerned about long-term side effects,” said Dr. Lee D. Katz, an X-ray at Yale University School of Medicine, referred to the doctor’s oath to “do no harm first.”
The FDA does not have to follow the advice or advice of its outside experts, but it usually does. A detailed study of the drug by FDA staff led to the same conclusions as the panel.
In a statement, Pfizer said it was disappointed with the vote on the drug, which has been under development for 15 years.
“We will continue to work with the FDA to determine the next steps,” said my intern, Rusnak, director general of internal medicine development.
During the two-day hearing, many experts said that danzumab did not work better than the non-steroidal anti-inflammatory drugs commonly used for arthritis pain, such as Aleve և Celebrex. They also expressed concern that although people were likely to take medication for many years, they were only one year behind the study participants in the longest study period.
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