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Gilead To File Filgotinib For RA in 2019, Earlier Than Forecast

 
• By Kevin Grogan

Concerns the Galapagos-partnered JAK inhibitor would be held back by a testicular toxicity study have been calmed by positive FDA talks and a submission is due before the end of the year.

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No more questions about timing for filgotinib filing • Source: Shutterstock

The US filing for rheumatoid arthritis (RA) of Gilead Sciences Inc. and Galapagos NV's closely watched filgotinib is now expected by the end of this year, allaying fears that the drug would be at a competitive disadvantage to AbbVie Inc.’s already-submitted rival JAK inhibitor upadacitinib.

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