Gilead Reports NDA Submission of Filgotinib to PMDA for Ulcerative Colitis in Japan

 Gilead Reports NDA Submission of Filgotinib to PMDA for Ulcerative Colitis in Japan

Gilead Reports NDA Submission of Filgotinib to PMDA for Ulcerative Colitis in Japan

Shots:

  • The submission is based on P-IIb/III SELECTION study evaluating the efficacy and safety of filgotinib (200mg, qd) vs PBO in patients with mod. to sev. active UC who had an inadequate response or were intolerant to either conventional therapy or a biological agent
  • Results: patients achieved clinical remission @10wks., maintained remission @ 58 wks. and no new safety risks were observed
  • The applications have been submitted to EMA and MHRA for mod. to sev. active UC and are currently under review. Filgotinib is approved and marketed as Jyseleca (200mg and 100mg tablets) in the EU, Great Britain, and Japan for mod. to sev. active RA

Click here to­ read full press release/ article | Ref: Globe Newswire | Image: Pharma Boardroom

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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