A US health adviser sharply criticized the experimental arthritis drug on Thursday, saying that restrictions on its use are too risky.
The Food and Drug Administration’s expert committee voted 19-1 that even with the proposed measures to limit who takes the drug, the modest benefits of the drug do not outweigh its considerable risk. did. Pfizer is seeking FDA approval for a drug called tanezumab to treat mild to moderate arthritic pain in the hips and knees. It is given by injection every two months.
In the study, a small percentage of participants had joint damage that worsened faster and required hip or knee replacement. Others had swelling and nerve damage. In some cases, healthy joints were damaged.
“I’m worried about long-term side effects,” said Dr. Lee D. Katz, a radiologist at Yale University School of Medicine, citing a doctor’s vow that “it doesn’t hurt at first.”
The FDA does not have to follow the recommendations or advice of outside experts, but it usually does. A detailed review of the drug by FDA staff came to the same conclusion as the panel.
Pfizer said in a statement that he was disappointed in voting for the drug, which has been in development for 15 years.
“We will continue to work with the FDA to determine the next steps,” said Jim Rusunak, Chief Development Officer for Internal Medicine.
During the two-day hearing, many experts found that tanezumab did not work better than non-steroidal anti-inflammatory drugs commonly used for arthritic pain such as Aleve and Celecoxib. They also raised concerns that while people were likely to have been taking the drug for years, study participants were only followed for about a year in the longest study.
Follow Linda A. Johnson on https://twitter.com/LindaJ_onPharma
The Associated Press’s Department of Health Sciences is supported by the Department of Science Education at the Howard Hughes Medical Institute. AP is solely responsible for all content.
The FDA panel rejected Pfizer’s arthritis drug because it was too risky
Source link The FDA panel rejected Pfizer’s arthritis drug because it was too risky
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