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Galapagos' Filgotinib Shows Interim Safety In Ongoing Studies

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Galapagos NV (NASDAQ: GLPG) has announced interim results from two ongoing safety studies investigating the effect of Jyseleca (filgotinib) on sperm parameters in males with inflammatory bowel disease (MANTA study) or rheumatic conditions (MANTA-RAy study).

  • Out of the 248 randomized patients, 240 reached Week 13 with two evaluable semen samples at baseline and Week 13. Of those, 18 patients showed more than 50% decline in sperm concentration, with 10/120 (8.3%) patients on placebo and 8/120 (6.7%) patients on filgotinib.
  • Patients who met this endpoint discontinued study treatment at Week 13, were switched to the standard of care treatment, and were monitored for reversibility every 13 weeks for up to 52 weeks.
  • These studies are not powered for statistical comparison between groups but will be submitted to relevant regulatory authorities.
  • Galapagos and Gilead intend to report additional results from these studies only after all patients in the monitoring phase have completed the protocol-defined observation period.
  • Filgotinib is approved and marketed as Jyseleca in Europe, Great Britain, and Japan to treat adults with moderately to severely active rheumatoid arthritis who have responded inadequately or are intolerant to one or more disease-modifying anti-rheumatic drugs.
  • Price Action: GLPG shares are trading higher by 4.28% at $85.84 in premarket trading on the last check Thursday.
 

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Posted-In: inflammatory bowel disease rheumatic conditionsBiotech News Health Care FDA General

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