The approval of Olumiant (baricitinib) 2 mg tablets as a once-daily oral medication for the treatment of adults with moderately-to-severely active rheumatoid arthritis (RA) by the FDA, will give global healthcare leader Eli Lilly and Delaware-based biopharma firm Incyte Corp. a head start over competitors in the RA market, says leading data and analytics company GlobalData.
Olumiant marks the second oral janus kinase (JAK) inhibitor to launch for RA in the US market following the launch of Pfizer’s Xeljanz (tofacitinib) in November 2012.
As Olumiant will have to compete with only Xeljanz in the immediate future, GlobalData anticipates the RA drug to generate sales of $768.9 million in the US in 2025.
However, the latest FDA approval comes with a boxed warning for the risk of serious infections, malignancies and thrombosis. It is indicated for patients who have had an inadequate response to one or more tumour necrosis factor (TNF) inhibitor therapies, posing a potential marketing challenge for Lilly and Incyte.
In April 2017, the regulator declined to clear the higher (4 mg) dose of the RA drug after an independent advisory panel voted against it regarding concerns related to safety profile.
Analysts opine that the approval of just the lower dose will limit the drug use in only TNF refractory patients and in turn the business opportunity for the partners.
Olumiant will especially face competition from not only Xeljanz, but also from AbbVie’s upadacitinib and Gilead/Galapagos’ filgotinib, both of which have met all primary endpoints in their Phase III trials.
In addition, they specifically inhibit JAK1, offering a better safety profile than either Olumiant or Xeljanz, marking a potential driver for AbbVie and Gilead/Galapagos.
Alexandra Annis, MS, Pharma Analyst at GlobalData, says: “Both upadactinib and filgotinib are expected to hit market in 2020 and 2021, respectively, at least 2 years after Olumiant’s launch in the US.”
“As Olumiant will only compete with Xeljanz in the immediate future, it will establish itself in the RA market.”
Incyte is now eligible to receive a $100 million milestone payment from Lilly as a result of the approval, which it expects to recognise by the end of the second quarter of 2018, when Lilly plans to launch Olumiant in the US.