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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.

Galapagos had excluded the higher daily 200mg dose in male subjects in the US in its DARWIN Phase II program in rheumatoid arthritis, because of FDA concerns about preclinical data...

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