Setback To Novartis: CDSCO Panel Rejects Lanalumab Phase III Trial Design Over Study Flaws
New Delhi: In a setback to Novartis, the Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has declined to approve the current design of the Phase III clinical trial protocol for its monoclonal antibody Lanalumab (VAY736), citing concerns over the study rationale and treatment strategy.
The firm had submitted Protocol No. CVAY736K12301E1 Version 00 dated 14 August 2024 for the committee’s consideration.
Lanalumab, also known as VAY736, is a monoclonal antibody targeting the BAFF receptor (BAFF-R). It is being investigated for autoimmune diseases such as Sjögren's syndrome, systemic lupus erythematosus (SLE), and multiple sclerosis.
At the SEC (Renal) meeting held on July 22, 2025, the expert panel deliberated on the protocol and concluded that the proposed study design could not be approved in its current format due to the following concerns:
The rationale for continuing treatment with the trial drug in individuals who showed no response after 144 weeks of therapy remains unclear.
Patients from the intervention or placebo arms who failed to attain either Partial Renal Response or Complete Renal Response were still being considered for enrollment into the Open Label Extension study. However, the continuation of the existing treatment regimen (Standard of Care) despite incomplete response lacks adequate justification.
The committee has directed Novartis to submit detailed clarifications and supporting data for further review.
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