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Filgotinib Progress At Higher Dose Justifies Gilead's Gamble

 
• By Eleanor Malone

News that Belgium's Galapagos and partner Gilead are to advance a higher dose of JAK1 inhibitor filgotinib into Phase III help allay lingering doubts over testicular toxicity with the drug, the rights to which AbbVie had unexpectedly handed back.

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Galapagos NV and partner Gilead Sciences Inc. have gained US and EU regulatory endorsement for a Phase III program of their oral Janus kinase 1 (JAK1) inhibitor filgotinib that includes both the 100mg dose allowed for its Phase II program, and also a higher 200mg dose that had previously been omitted from some of its trials in humans because of concerns about testicular toxicity.

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