Lupin Gets CDSCO Panel Nod To Manufacture, Market FDC of Glycopyrronium, Vilanterol Inhalation Powder
New Delhi: The drug major Lupin has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to manufacture and market the fixed-dose combination (FDC) of Glycopyrronium Bromide plus Vilanterol Trifenatate (50µg Ph.Eur + 25µg) Inhalation Powder.
This came after the drug major Lupin presented its proposal before the committee along with the Phase III clinical trial report conducted by Contract Research Organization (CRO) JSS Medical Research Asia Pacific Private Limited and justification for the bioequivalence (BE) study waiver.
The firm informed the committee that the proposed Phase III clinical trial study was conducted by CRO M/s JSS Medical Research Asia Pacific Private Limited and M/s Lupin Ltd. was the sponsor of the study.
Glycopyrronium bromide belongs to a group of medicines called “anticholinergics”. Glycopyrronium is a muscarinic antagonist with the highest affinity for M1 receptors, followed by M3, M2/M4, and M5. These medicines help to prevent the formation of secretions that can cause problems in the respiratory tract. Glycopyrrolate inhibits parasympathetic nerve impulses by selectively blocking the binding of acetylcholine to muscarinic receptors.
Vilanterol is a long-acting beta2-adrenergic agonist used in combination with other bronchodilators for the management of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
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 the lungs mediate bronchoconstriction, so blockade of these receptors leads to bronchodilation.
At the recent SEC meeting for Pulmonary held on 21st August 2023, the expert panel reviewed the proposal presented by the drug major Lupin along with the Phase III clinical trial report conducted by Contract Research Organization (CRO) JSS Medical Research Asia Pacific Private Limited.
The firm informed the committee that the proposed Phase III clinical trial study was conducted by CRO JSS Medical Research Asia Pacific Private Limited and Lupin was the sponsor of the study.
After detailed deliberation, the committee recommended the grant of permission for manufacturing and marketing of the proposed FDC, subject to the condition that the firm should conduct a Phase IV clinical trial.
Accordingly, the expert panel suggested that the firm should submit the Phase IV clinical trial protocol to CDSCO within 03 months of approval for review by the committee.
