Novartis Gets CDSCO Panel Nod to study Remibrutinib to treat chronic spontaneous urticaria
New Delhi: The drug major Novartis has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to conduct the phase III clinical trial of Remibrutinib (LOU064) in patients with chronic spontaneous urticaria (CSU).
This came after the drug major Novartis presented the proposal to grant phase III Clinical trial permission with protocol no. CLOU064A2303B.
Remibrutinib (LOU064), an oral, highly selective Bruton tyrosine kinase inhibitor, offers fast disease control in patients with chronic spontaneous urticaria (CSU) who remain symptomatic despite treatment with second-generation H1 antihistamines. It is currently in phase 3 development for chronic spontaneous urticaria (CSU).
Chronic spontaneous urticaria (CSU) is a debilitating skin disease characterized by intensely itchy wheals, angioedema, or both. Symptoms recur spontaneously, on a near-daily basis, over >6 weeks; many patients experience flare-ups over several years and, consequently, reduced quality of life.
The drug "demonstrated clinically significant and statistically significant reduction in urticaria activity vs placebo" in a Phase III study, Novartis reported in November 2023.
At the recent SEC meeting for dermatology and allergy held on the 9th of November 2023, the expert panel reviewed the proposal presented by the drug major Novartis for the grant of phase III Clinical trial permission with protocol no. CLOU064A2303B.
After detailed deliberation, the committee recommended a grant of permission to conduct the trial as presented by the firm.
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