As Gilead Sciences and its development partner Galapagos NV eye filing a New Drug Application with the U.S. Food and Drug Administration (FDA) for its JAK inhibitor filgotinib, the companies’ hopes have been boosted by new 52-week safety data.
This morning, the two companies released updated information for the Phase III trials supporting the NDA for filgotinib as a treatment for moderate to severe rheumatoid arthritis. While full details of the updated results were not shares, Gilead and Galapagos said the information will be released at an upcoming conference. The companies did note that the data from the 52-week study are “consistent with and support” the efficacy, safety and tolerability profiles demonstrated in the Week 12 and 24 analyses presented earlier this year.
“These recent updates from the FINCH 1 and 3 trials continue to provide consistent evidence to support filgotinib’s profile in RA patients. 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,” said Walid Abi-Saab, Galapagos’ chief medical officer said in a statement.
Gilead and Galapagos are seeking regulatory approval of filgotinib in the United States, Japan and Europe. Applications for marketing authorization have been filed in Europe and Japan. The companies soon plan to file in the United States, although no timeline has been provided.