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

Written By : Dr. Divya Colin |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-05-21T17:30:47+05:30 | Updated On 21 May 2024 5:30 PM IST

New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the protocol amendment proposal presented by the drug major Novartis for an extension study of long-term efficacy, safety, and tolerability of Remibrutinib in chronic spontaneous urticaria patients who completed preceding studies with remibrutinib.

This came after the drug maker Novartis presented protocol amendment version 01 dated 28.02.2024 protocol No. CLOU064A2303B.

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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Remibrutinibcdsconovartisprotocol amendmentChronic spontaneous urticaria

Dr. Divya Colin

Doctor of Pharmacy

Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.

Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751