Post-Marketing Xeljanz Safety Study Results Revealed


Post-Marketing Xeljanz Safety Study Results Revealed

postmarketing Xeljanz safety study

A post-marketing Xeljanz lawyer XMR-520 study has shown that the drug did not increase the risk of death or cardiovascular events. In addition, two doses of the drug failed to reach the primary endpoints, resulting in a “black box” warning. However, despite the FDA’s warning, Xeljanz is still a hot seller, and Pfizer is hoping to capitalize on the new data by updating the drug’s label.

Correcting Any Problems With An Approved Drug

While the post-marketing Xeljanz study was not a formal recall, it is a crucial piece of the safety puzzle. It provides vital information about drug safety, and allows doctors to evaluate risk factors in a more comprehensive way. In addition, FDA monitors these studies to ensure their safe and efficient completion. FDA-sponsored post-marketing studies are vital for identifying and correcting any problems with an approved drug.

Pfizer, which markets Xeljanz as a safe, effective treatment for ulcerative colitis, is facing competition from other TNF inhibitors. AbbVie has Humira, an RA drug approved by the FDA. It is pursuing approval for ulcerative colitis as well. AbbVie recently released phase 2b/3 results, demonstrating a 26% rate of remission among patients treated with the drug.

The results of the post-marketing Xeljanz clinical trial have been published in JAMA. The co-primary endpoints were adverse cardiovascular events and adjudicated malignancies. In addition, patients were treated with a TNF inhibitor to reduce the risk of cardiovascular complications. Overall, the drug was well tolerated in this study. However, Pfizer is continuing to monitor the safety of Xeljanz.

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