In a statement Friday, Lilly said the FDA has requested additional clinical data to determine appropriate doses of baricitinib. The FDA also asked for more safety data.
Baricitinib was expected to secure U.S. approval and deliver $2 billion or more in peak sales as the most effective, once-daily oral JAK inhibitor for rheumatoid arthritis, supplanting Pfizer's Xeljanz. Lilly was counting on the greater efficacy of a higher baricitinib dose to separate from Xeljanz. If Lilly can only move forward with a lower, 2 mg dose of baricitinib, it risks losing an efficacy advantage over its oral JAK inhibitor competitor.
The FDA action was a win for Pfizer because Xeljanz escapes competition for one year maybe even longer.
Gilead wins because its oral JAK inhibitor filgotinib -- currently in a phase III study for rheumatoid arthritis, among other indications -- has a good chance to catch up.REGN) and Sanofi ( SNY) win because they'll now have more time to establish a marketing presence for their IL-6 inhibitor sarilumab, assuming the injected drug can overcome a manufacturing delay and win FDA approval later this year.