Eli Lilly is preparing to file again for FDA approval of rheumatoid arthritis drug baricitinib (Olumiant) by the end of January—this time with new information about the drug’s safety and efficacy.
The FDA rejected the Indianapolis pharmaceutical company’s initial drug application in April. In July, Lilly (NYSE: LLY) said discussions with the regulator included the possibility of requiring an additional study. Lilly said the FDA had expressed concern about blood clots observed during clinical trials and it asked the company to provide more information about dosing and safety.
Lilly will now try to provide the data that the FDA wants without conducting another study. The company said Wednesday that its new January goal—months earlier than the 18-month delay that the company forecast in July—was set after additional discussions with the regulator late this month. The filing will be a Class 2 resubmission, an agreement between a company and the FDA to start a six-month review cycle for a drug after the FDA receives the application. Under that timeline, an FDA decision could come by the end of July 2018.
Rheumatoid arthritis is an autoimmune disorder in which the immune system mistakenly attacks joint tissues, causing swelling and pain. Baricitinib is a once-daily pill that blocks proteins associated with this inflammation. In 2009, Lilly licensed global rights to the drug from Wilmington, DE-based Incyte (NASDAQ: INCY).
The European Commission approved baricitinib in February. That month, the New England Journal of Medicine published results from a Phase 3 clinical trial that compared the Lilly drug to adalimumab (Humira), an injectable biologic drug that generates blockbuster sales for AbbVie (NYSE: ABBV). Baricitinib beat AbbVie’s drug in the study, and Lilly was widely expected to win FDA approval.
In the months following the FDA’s surprise rejection of baricitinib, regulators in Europe have agreed to update the drug’s label with additional warnings for patients at risk for deep vein thrombosis and pulmonary embolism. Baricitinib was approved in Japan last month. Lilly says that the drug’s label in that country includes precautions about the cardiovascular risks.