- Eli Lilly & Co. will have another shot at securing approval for its rejected arthritis drug baricitinib sooner than it previously expected, announcing Wednesday it will resubmit an application to the Food and Drug Administration before the end of January 2018.
- In July, the drugmaker had said a second attempt to win a regulatory OK in the U.S. likely wouldn't come until 2019 as it sorted out the FDA's concerns over barictinib's safety. Such worries led the agency to initially reject the drug this past April.
- News of the sped-up timeline lifted shares in the company higher by nearly 2% Wednesday morning. Baricitinib is a key pipeline candidate for Lilly and could help bolster future revenue growth as the market for the company's diabetes portfolio tightens.
In July, when Lilly sketched out a minimum 18-month turnaround to refile bariticinib, company CEO David Ricks emphasized the drugmaker's disagreement with the FDA's rationale for rejecting baricitinib.
The regulator originally asked for another clinical study to clarify whether the drug was causing thromboembolic adverse events, such as deep vein thrombosis or pulmonary embolism. Five patients who took barictinib in Lilly's studies did experience blood clots, but Lilly argued the overall event rate did not differ from what would be expected from a rheumatoid arthritis patient population.
Conducting another trial would have been a costly delay, further setting back Lilly's hopes of breaking into inflammatory disease markets with the JAK inhibitor.
A second meeting with the FDA in late August, though, appears to have resolved the differences between Lilly and the regulator, clearing a path for a much sooner resubmission.
Lilly said it expects the FDA to classify a refiled application as a Class 2 resubmission, which indicates a six-month review cycle. New safety and efficacy data for baricitinib, likely aimed at allaying the FDA's concerns, will be included in the application.
This new data is from extension studies of baricitinib, a Phase 2 Asian study and an ongoing trial in atopic dermatitis, according to an August 30 note from Cowen & Company analyst Steve Scala.
Notably, a January resubmission and six-month review means baricitinib could secure approval as early as mid-2018, roughly a year earlier than would have been expected under Lilly's July timeline for refiling.
"It is not known whether refiling and the subsequent review will prompt an FDA [advisory committee]," Scala wrote in the August 30 note. "However, we think an Adcom could be a positive step toward full approval."
Shares in Incyte, Lilly's partner on baricitinib, also rose Wednesday, trading about 5% above Tuesday's close.
Despite this step forward, the delays could add up for baricitinib. Sales of Pfizer Inc.'s rival JAK inhibitor Xeljanz (tofacitinib) have grown strongly and the drug is on pace to become a blockbuster seller this year. Other entrants, like Sanofi SA and Regeneron Pharmaceuticals, Inc.'s Kevzara (sarilumab), add to an already crowded arthritis market.