CT waiver not considered, Conduct BA study: CDSCO Panel Tells Sun Pharma on Pulmonary FDC

New Delhi: Denying to consider the clinical trial waiver proposal for the fixed dose combination (FDC) Vilanterol Trifenatate plus Umeclidinium Bromide Dry Powder Inhaler in capsule, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the drug major Sun Pharma Laboratories to conduct the bioavailability (BA) study of Vilanterol Trifenatate equivalent to Vilanterol 25mcg plus Umeclidinium Bromide equivalent to Umeclidinium 62.5mcg Dry Powder Inhaler in capsule.

This came after the drug maker Sun Pharma Laboratories presented the proposal along with comparative BA study protocol and justification for CT waiver before the committee.

Vilanterol trifenatate, a novel inhaled long-acting beta2 adrenoceptor agonist, is well tolerated in healthy subjects and demonstrates prolonged bronchodilation in subjects with asthma and COPD.

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

Umeclidinium is a long-acting muscarinic antagonist used as a long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD).

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 5th March 2024, the expert panel reviewed the proposal presented by drug major Sun Pharma along with the comparative BA study protocol and justification for the CT waiver of the pulmonary FDC Vilanterol Trifenatate plus Umeclidinium Bromide Dry Powder Inhaler in capsule

After detailed deliberation, the committee recommended that the firm should conduct a BA study and the clinical trial waiver was not considered at this stage.

Accordingly, the expert panel suggested that the result of the BA study should be presented before the committee for further review of waiver of clinical trial study

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