Gilead and Galapagos have said that 52-week phase 3 data for JAK1 inhibitor filgotinib in rheumatoid arthritis are consistent with earlier readouts. The update comes as Gilead prepares to make the case that filgotinib is safe and effective to the FDA.
The 52-week update relates to two phase 3 trials, FINCH 1 and FINCH 3, that first delivered data in March. Those original readouts showed filgotinib is better than methotrexate alone and suggested it has an edge over AbbVies Humira, the aging blockbuster rheumatoid arthritis incumbent. Gilead has since used the data in filings for approval in Europe and Japan, with a U.S. submission set to follow.
Results shared to date suggest Gilead has enough positive evidence to get filgotinib approved. The harder question is whether the evidence is strong enough to get filgotinib a cleaner label than its rivals or otherwise give it an advantage that translates into the hoped-for big blockbuster sales.
The update shared by Gilead and Galapagos late yesterday offers little additional insight to inform an assessment of that question. The update lacked any data, with Gilead and Galapagos limiting the new information to little more than a statement that the 52-week findings are consistent with and support the efficacy, safety and tolerability profiles demonstrated in the week 12 and 24 analyses.
In the second half of the FINCH 1 and FINCH 3 trials, filgotinib exhibited the same favorable safety profile seen in the first 24 weeks, including similar rates of thrombotic events as previously observed, as well as persistent efficacy, Walid Abi-Saab, chief medical officer at Galapagos, said in a statement.
While that is an incremental positive for Gilead and Galapagos, exactly what it means for filgotinib will only become clear when detailed data are shared and, in particular, once the FDA and other regulatory agencies offer their opinions.
The agencies position on the safety of filgotinib is a particular source of ongoing uncertainty. Gilead and Galapagos think filgotinib is free from some of the safety problems that blighted Pfizer's Xeljanz and Eli Lilly's Olumiant, which hit multiple members of the JAK family. However, AbbVies Rinvoq, which, like filgotinib, is specific to JAK1, received a black box warning when it won FDA approval earlier this year.