(RTTNews) – Kezar Life Sciences (KZR) said the FDA Division of Hepatology and Nutrition has granted the company a Type C meeting for the first quarter to discuss the development of zetomipzomib, a selective inhibitor of the immunoproteasome, in patients with autoimmune hepatitis. The Type C meeting will involve review of a potential global, randomized Phase 2b clinical study of zetomipzomib in patients with relapsed and refractory AIH.
Chris Kirk, CEO of Kezar Life Sciences, said: “The additional safety and pharmacokinetic data analysis performed in response to prior FDA feedback further support our belief that zetomipzomib has the potential to change the treatment landscape in this serious disease. Furthermore, achieving alignment with the FDA on endpoints and trial conduct would provide a clear development pathway for this therapy.”
In pre-market trading on NasdaqCM, Kezar Life Sciences shares are down 2.3 percent to $6.35.
For More Such Health News, visit rttnews.com.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
#Kezar #Life #Sciences #FDA #Division #Grants #Type #Meeting #Discuss #Development #Zetomipzomib