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

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

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

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

Click here to­ read the full press release 

Tuba

Tuba was Senior Editor at PharmaShots. She was curious, creative, and passionate about recent updates and innovations in the life sciences industry. She covered Biopharma, MedTech, and Digital health segments. Tuba also had an experience in digital and social media marketing and ran the campaigns independently. She can be contacted at connect@pharmashots.com.

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