Pfizer’s Arthritis Drug May Have Lower Market Potential if Cancer Risk Limits Labeling

Approval of Pfizer’s rheumatoid arthritis (RA) drug tofacitinib may be delayed as the FDA reviews an additional analysis of data in the application that it requested. How the agency views the drug’s safety will be crucial to tofacitinib’s labeling and market opportunity.

RA is treated in a stepwise manner with general disease-modifying drugs (DMARDs) like methotrexate first and then with biologics like anti-TNFs. An oral drug like tofacitinib, if approved for use before and after injectable biologics, may represent a multibillion- dollar opportunity. While Pfizer’s clinical trials support the use of tofacitinib before and after anti-TNFs, the FDA’s view on safety probably will determine uptake of the drug among rheumatologists.

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