Company: Gilead Sciences
Used for: rheumatoid arthritis
Est. 2024 sales: $1.28 billion
Gilead Sciences, with its hepatitis C glory days behind it, is working to push into the anti-inflammatory market. And with an FDA filing now under speedy review, rheumatoid arthritis candidate filgotinib could go a long way to helping Gilead toward that goal.
While the FDA hasn't listed a decision date, filgotinib is already under review at the agency and could rake in global sales of $1.28 billion in 2024, according to EvaluatePharma. The FDA accepted Gilead's application in late December with a priority review voucher attached, likely spelling a speedy review and decision from the administration.
At the J.P. Morgan Healthcare Conference in January, Gilead commercial chief Johanna Mercier focused on the strength of filgotinib's clinical data and said physician feedback has so far been very positive. The company foresees a total of five indications for filgotinib launching in the next four years, so it’s keeping not only the short term but also the medium-to-long term in mind, she said.
Filgotinib has already been filed for approval in Europe and Japan, but the U.S. market is where the big bucks will come from, making this an important milestone for Gilead. The Big Biotech has long had a stake in filgotinib, with recent data readouts showing the medication is better than methotrexate alone while suggesting it has an edge over AbbVie’s Humira, the aging blockbuster rheumatoid arthritis incumbent.
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 blockbuster sales.
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, along with other members of the JAK family. However, AbbVie’s Rinvoq, which, like filgotinib, is specific to JAK1, received a black box warning when it won FDA approval earlier this year.