Incyte Corporation (NASDAQ:INCY) and Eli Lilly and Co (NYSE:LLY) have revealed plans to resubmit baricitinib, an arthritis candidate that was rejected by the Food and Drug Administration, before February next year. This means that the drug could possibly be approved by mid-2018. It also means that the FDA will not require another clinical trial to be conducted and this will significantly cut down on the timeframe for the launch of the drug.
“We are pleased with the opportunity to provide our resubmission package for baricitinib sooner than anticipated and look forward to continuing to work with the FDA,” said Lilly Bio-Medicines’ president Christi Shaw.
Class II category
According to Incyte and Lilly, the expectation is that their application be classified by the FDA as a resubmission in the Class II category and this will begin a review cycle lasting half a year. That is expected to shorten the period before baricitinib can challenge tofacitinib, a JAK inhibitor developed by Pfizer. Tofacitinib is headed for blockbuster status with sales having grown by over 40% to reach a figure of $587 million in this year’s first half.
The shortened review period will also reduce chances of baricitinib being leapfrogged by several other JAK inhibitors which are currently in late-phase trials. This includes filgotinib which has been developed by Gilead Sciences, Inc. (NASDAQ:GILD) and upadacitinib which has been developed by AbbVie Inc (NYSE:ABBV). Both are expected to be future blockbusters.
Safety and efficacy
Incyte and Lilly have confirmed that in their dossier they will include evidence showing how safe the drug is as well as new efficacy data. In a complete response letter sent by the Food and Drug Administration concerns were expressed over the thromboembolic events which were witnessed in both the second and third phases of the trials.
According to Pfizer Inc. (NYSE:PFE), there has not been any evidence indicating thrombosis when Xeljanz was used. This suggests that if the problem is limited to baricitinib, then the drug would become an also-run. Before the complete response letter from the FDA it had been projected that sales of baricitinib would reach approximately $2 billion.
On Wednesday shares of Eli Lilly and Co rose by 2.47% to close the day at $80.49.
