Insufficient Efficacy, Safety Data: CDSCO Panel Rejects Zydus' Phase III CT Waiver Request for Voclosporin
New Delhi: Citing lack of sufficient efficacy and safety data to prove that the dose requirement in the Indian population is adequate, the Subject Expert Committee (SEC), functioning under the Central Drug Standard Control Organisation (CDSCO), has rejected Zydus Lifesciences' proposal to conduct a phase III clinical trial of Voclosporin capsule 7.9 mg.
This came after the firm presented a bioequivalence (BE) study report and justification of the Phase III local clinical trial waiver before the committee.
The Committee considered the BE study results. However, the expert panel noted that the data presented with respect to orphan drug status is anecdotal.
Accordingly, the expert panel requested the firm to submit adequate data to substantiate the orphan drug status in the Indian context.
Voclosporin is a calcineurin inhibitor for the treatment of lupus nephritis (LN) in patients diagnosed with systemic lupus erythematosus (SLE).Through the inhibition of calcineurin, voclosporin blocks IL-2 expression and T-cell mediated immune responses, stabilizing podocytes in the kidneys
Lupus nephritis (LN) is a type of glomerulonephritis occurring in patients with systemic lupus erythematosus (SLE). LN is a significant cause of renal failure, morbidity, and death in patients with SLE. Within 10 years of being diagnosed with SLE, 5-20% of those suffering from LN develop end-stage kidney disease, a fatal condition. Early and accurate intervention for LN is important in improving clinical outcomes.
At the recent SEC meeting the expert panel reviewed the bioequivalence (BE) study report and justification of the Phase III local clinical trial waiverher
Furthermore, there are concerns over the safety profile of the drug in the Indian population, as the published study data included Asian patients but not patients from India specifically, the committee noted.
The committee also noted that dose titration of the drug in the Indian population is required.
In view of the above, the committee is of the opinion that there is a lack of sufficient efficacy and safety data to prove that the dose requirement in Indian population is adequate.
In addition, the data on the course of dose titration is also inadequate considering the safety profile of the drug. Therefore, the expert panel stated that the firm is required to submit data proving that there is no substantial ethnic variability.
After detailed deliberation, the committee didn’t agree to Phase-III CT waiver at this stage.
