Gilead and Galapagos’ Jyseleca (filgotinib) Receive the CHMP’s Positive Opinion for Moderate to Severe Rheumatoid Arthritis

July 24, 2020 Auto Bot CHMP, Filgotinib, Galapagos, Gilead, Latest, Moderate, Pharma, Positive Opinion, Receive, regulatory, rheumatoid arthritis, Severe 0

Shots:

  • Then CHMP’s positive opinion is based on P-III FINCH and P-II DARWIN programs that included 4,544 RA patient-years of experience with filgotinib. All three FINCH trials involve a broad range of patients that met their 1EPs
  •  In the trials, the drug achieved ACR20/50/70 and DAS28(CRP)<2.6. Moreover, Filgotinib inhibited the progression of structural joint damage assessed by mTSS compared with PBO
  • Across the FINCH and DARWIN trials, filgotinib(qd) demonstrated a clinical safety profile when administered as monothx./ in combination with MTX. The company expects the EC’s decision in Q3’20

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