The FDA handed Gilead Sciences and its partner Galapagos a surprising no-go for blockbuster hopeful filgotinib last month. But that didn’t stop regulators in Japan from making a different decision on the rheumatoid arthritis drug.
The country’s Ministry of Health, Labour and Welfare approved filgotinib, to be sold under the brand name Jyseleca, to treat rheumatoid arthritis in patients who haven’t responded well to conventional therapies, Gilead and its local distribution partner Eisai said Friday.
The Japanese green light was based on results from the Darwin phase 2 and Finch phase 3 trials—the same tests that led to the FDA's complete response letter.
The U.S. agency raised concerns about sperm toxicity, especially for the higher, 200-mg dose. The CRL requested data from two ongoing trials, Manta and Manta-Ray, that are focused on assessing the 200-mg dose’s effect on sperm but won’t read out until 2021. The Japan go-ahead covers the 200 mg and 100 mg tablets.
Jyseleca is the centerpiece of Gilead’s initial Galapagos collaboration and a key part of its plan to branch out beyond antiviral drugs. But industry watchers have been split about the drug’s potential.
Bulls have pegged the drug as a blockbuster, siding with Gilead management in pointing out some competitor drugs’ heart-related side effects, which Jyseleca hasn’t shown. But as Wolfe Research analyst Tim Anderson wrote in an August note after the FDA snub, the drug could struggle commercially, “if only because it’s a late entrant into a crowded category, dominated by deep-pocketed Big Pharma companies who know the immunology and inflammation space much better than Gilead does.”
One key player is AbbVie, which made huge waves in the rheumatoid arthritis market with Humira. In fact, it was AbbVie that years ago surprised pharma watchers by dropping its opt-in for the drug now known as Jyseleca. But aside from Pfizer’s stalwart Xeljanz, the Gilead drug's true rival is AbbVie's newly approved JAK inhibitor Rinvoq.
“With Rinvoq already off to a robust start in RA, we think this development has to make AbbVie’s commercial efforts that much easier,” Piper Sandler analysts wrote in a recent note, referring to Jyseleca’s FDA setback.