Shaking Off US Rebuff, Gilead And Galapagos Get Filgotinib Green Lights In EU And Japan
First Ever Approvals For Belgian Biotech
Galapagos and Gilead's JAK inhibitor has been approved for rheumatoid arthritis in the second and third biggest pharma markets, softening the blow somewhat of rejection from the US FDA in the biggest market last month.
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Bristol Myers Squibb reported detailed results from the Phase III TRUE NORTH study that show durable remissions in a patient population that switches therapies due to loss of response.
Japan approves a batch of new products and indications, including Daiichi Sankyo's Enhertu in a high-need indication after a rapid review and Takeda's Zejula, which will be made available to selected patients before its reimbursement listing.
It has been a tough couple of months for the Belgian biotech since the FDA surprisingly rebuffed its JAK inhibitor filgotinib but promising data on the oral autotaxin inhibitor ziritaxestat helped soften the blow and drive up Galapagos stock.