Inventiva’s Lanifibranor Receives the US FDA’s Breakthrough Designation for the Treatment of NASH

 Inventiva’s Lanifibranor Receives the US FDA’s Breakthrough Designation for the Treatment of NASH

Inventiva’s Lanifibranor Receives the US FDA’s Breakthrough Designation for the Treatment of NASH

Shots:

  • The designation is based on the P-IIb NATIVE trial involves assessing lanifibranor vs PBO in patients with NASH for 24wks. Lanifibranor is the first drug candidate to be granted BTD in NASH since 2015
  • The study met its 1EPs i.e. demonstrated significant reduction of SAF and 2EPs, including NASH resolution with no worsening of fibrosis, improvement of liver fibrosis with no worsening of NASH in both ITT and PP populations
  • The company expected to hold the end of the P-IIb NATIVE trial meeting with the FDA and to receive regulatory feedback from the EMA in Q4’20. The designation supports the decision to initiate the P-III trial of lanifibranor in H1’21

Click here ­to­ read full press release/ article | Ref: GlobeNewswire | Image: Twitter

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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