FDA Responds to Baricitinib New Drug Application
The U.S. Food and Drug Administration (FDA) issued a complete response letter to the New Drug Application (NDA) for baricitinib, a once daily oral JAK inhibitor that is seeking approval to treat moderate to severe rheumatoid arthritis (RA). The FDA refused to approve the application in its current form, saying that additional clinical data are needed to determine the most appropriate doses. The FDA also stated that additional data are necessary to further characterize safety concerns across treatment arms.1
The manufacturers, Eli Lilly and Incyte Corp., will continue to work with the FDA toward the approval of baricitinib. The manufacturers conducted four successful Phase 3 clinical trials with baricitinib as a treatment for patients with moderate to severe active RA, including the RA-BEGIN and RA-BEAM studies. The clinical trials included wide ranges of patients, such as those who were methotrexate naive and inadequate responders to methotrexate, as well as inadequate responders to conventional synthetic disease-modifying anti-rheumatic drugs (DMARDs) and biologic DMARDs, including TNF inhibitors.
Baricitinib was approved for use in the European Union in February 2017.
No REMS for Erythropoiesis-Stimulating Agents
The erythropoiesis-stimulating agents (ESAs), epoetin alfa and darbepoetin alfa, are FDA approved for treating anemia due to chronic kidney disease, chemotherapy and HIV treatments, as well as to reduce the number of blood transfusions associated with certain major surgeries. Recently, the FDA determined that the Risk Evaluation and Mitigation Strategy (REMS) for these treatments is no longer needed for their use in patients with myelosuppressive chemotherapy-related anemia. This change will ensure that the benefits of using these ESAs outweigh their risks of shortening overall survival and/or increasing risk of tumor progression or recurrence in patients with cancer.2
Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.
- Eli Lilly and Company. News release: U.S. FDA issues complete response letter for baricitinib. 2017 Apr 14.
- U.S. Food and Drug Administration. Post-market drug safety information for patients and providers: Information on erythropoiesis-stimulating agents (ESAs) epoetin alfa (marketed as Procrit, Epogen), darbepoetin alfa (marketed as Aranesp). 2017 Apr 13.