Shots:

• The 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

  Ref: Businesswire | Image: Pharmashots