Zydus Healthcare Gets CDSCO Panel Nod To study Vilanterol plus Umeclidinium powder for inhalation

Umeclidinium bromide/vilanterol trifenatate inhalation powder is indicated for the long-term, once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

Umeclidinium blocks muscarinic M3 receptors. M3 receptors in lungs mediate bronchoconstriction, so blockade of these receptors leads to bronchodilation. Vilanterol stimulates beta-2 receptors in the lungs. Beta-2 receptors mediate bronchodilation, so stimulation of these receptors leads to bronchodilation.

At the recent SEC meeting for Pulmonary held on 11th March 2025, the expert panel reviewed the proposal along with the Phase III CT protocol of the FDC Vilanterol Trifenatate plus Umeclidinium Bromide Powder for Inhalation.

After detailed deliberation, the committee recommended the grant of permission to conduct a Phase III clinical trial, subject to the condition that severe COPD patients with an inspiratory flow rate of less than 30 liters per minute must be excluded from the study.

Accordingly, the expert panel suggested that the revised phase III CT protocol should be submitted to CDSCO for review.

Further, the committee added that after approval from CDSCO, the firm should submit the Phase III CT report to CDSCO for further review by the committee.

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