- Eli Lilly and partner Incyte have secured a Food and Drug Administration approval for their Janus kinase (JAK) inhibitor baricitinib to treat moderate-to-severe rheumatoid arthritis in patients who haven't responded well to TNF inhibitors.
- The agency only OK'd the lower 2 mg dose, however, and not the more efficacious 4 mg dose. An advisory committee narrowly recommended an approval, but had expressed concerns about safety issues. Lilly will be required to conduct a long-term safety trial.
- The drug will be launched in the second quarter under the brand name Olumiant. It will carry a boxed warning "for the risk of serious infections, malignancies and thrombosis," similar to boxed warnings on already marketed JAK inhibitors like Pfizer's Xeljanz (although the Xeljanz label does not include the thrombosis warning).
Lilly has been fighting tooth and nail to gain approval for baricitinib for some time. After a three-month delay on its original user fee action date, the FDA issued a Complete Response Letter for the drug in April 2017. At one point, many thought Lilly might abandon the drug altogether.
While the approval is a win for both companies — Incyte will get a $100 million milestone payment for the approval — Lilly faces an uphill battle in commercializing the drug. The rheumatoid arthritis marketed is dominated by blockbuster TNF inhibitors, including the world's bestselling drug Humira (adalimumab). Biosimilars of some of these drugs have already started to enter the market as well, increasing competition. Other new mechanisms of action have also entered the market in recent years, and Xeljanz has a several year head-start, plus long-term safety data under its belt.
The lower dose that Lilly got approved also appears less effective than Xeljanz, although there have not been direct comparison studies. "Ultimately this label means that Olumiant is likely to be restricted to salvage therapy only, and expect forecasts for the product to decline even further," wrote Leerink analyst Geoffrey Porges in a note to investors.
But Lilly is hoping that a lower price-tag can give it an edge. The company is launching the drug with a wholesale acquisition cost of $25,000 per year, 60% below Humira's list price of $60,000 per year, said Lilly.
Price might not be enough, though. Other JAK inhibitors in development from both AbbVie and Gilead Sciences are looking positive in clinical trials. "Of the JAK class, we expect Xeljanz to continue to increase share
in first-line (pre-TNF), and anticipate AbbVie and Gilead’s JAK1 inhibitors upadacitinib and filgotinib to corner the second-line market based on superior efficacy in that setting, but only if their higher doses are approved without similar thrombotic safety limitations," added Porges.