CDSCO Panel grants Novartis Protocol Amendment Proposal to study Remibrutinib in Chronic Spontaneous Urticaria

The official title of the study is “A multicenter, double-blind, placebo-controlled, randomized withdrawal and open-label extension study followed by long-term open-label treatment cycles to assess the efficacy, safety and tolerability of remibrutinib (LOU064) in adult chronic spontaneous urticaria patients who completed the preceding remibrutinib Phase 3 studies”

The purpose of this extension study is to collect long-term efficacy, safety, and tolerability data on remibrutinib in a selected group of participants with Chronic Spontaneous Urticaria (CSU) who previously completed the treatment phase of remibrutinib preceding Phase 3 studies.

This study will also fulfill the Novartis commitment to provide post-trial access to participants who have completed the preceding Phase 3 studies, where applicable.

Chronic spontaneous urticaria is defined as the occurrence of wheals and/or angioedema for a total duration of six weeks or more.

LOU064 is also known as Remibrutinib. LOU064 exhibits an exquisite kinase selectivity due to binding to an inactive conformation of BTK and has the potential for a best-in-class covalent BTK inhibitor for the treatment of autoimmune diseases.

Remibrutinib blocks BTK and prevents the release of histamine that causes itchy hives (wheals) and/or deep tissue swelling (angioedema).

At the recent SEC meeting for dermatology and allergy held on the 14th of May 2024, the expert panel reviewed the protocol amendment version 01 dated 28.02.2024 protocol No. CLOU064A2303B.

After detailed deliberation, the committee recommended the approval of the protocol amendment as presented by the firm.

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