Zydus Healthcare Gets CDSCO Panel Nod To study Vilanterol plus Umeclidinium powder for inhalation
New Delhi: Zydus Healthcare 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 the fixed-dose combination (FDC) pulmonary drug Vilanterol 25 mcg plus Umeclidinium 62.5 mcg powder for inhalation.
However, this approval is subject to the condition that severe chronic obstructive pulmonary disease (COPD) patients with an inspiratory flow rate of less than 30 liters per minute must be excluded from the study.
In addition, the committee recommended that the firm should submit the revised phase III clinical trial protocol of the proposed FDC.
This came after the firm presented the proposal along with the Phase III CT protocol before the committee.
Umeclidinium bromide plus vilanterol trifenatate is a long-acting muscarinic antagonist/beta2-agonist (LAMA/LABA) combination dry powder for oral inhalation bronchodilator product.
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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