Conduct clinical trial in Indian patient: CDSCO panel tells Glenmark on pulmonary drug study

New Delhi: The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) has directed Glenmark to conduct a Phase 3 clinical trial of  Indacaterol (as acetate) and Mometasonefuroate Dry Powder for Inhalation (DPI) in Capsules in Indian patient for which protocol should be submitted.

This came after the firm presented their proposal for conduct of Bioequivalence (BA) Study along with justification for local clinical trial waiver before the committee.

Indacaterol is an inhaled long-acting beta-2 adrenergic agonist used to relax bronchial smooth muscle and improve symptoms and airflow obstruction caused by Chronic Obstructive Pulmonary Disease (COPD) and moderate to severe asthma.

Mometasone furoate is a corticosteroid drug that can be used for the treatment of asthma, rhinitis, and certain skin conditionsLabel. It has a glucocorticoid receptor binding affinity 22 times stronger than dexamethasone and higher than many other corticosteroids as well. Mometasone furoate is formulated as a dry powder inhaler, nasal spray, and ointment for its different indications.

At the recent SEC meeting for pulmonary dated 07.12.2021, the committee reviewed the drug maker Glenmark's proposal for conducting of BA Study along with justification for local clinical trial waiver in respect to the Indacaterol (as acetate) and Mometasonefuroate Dry Powder for Inhalation (DPI) in Capsules.

After detailed deliberation, the committee recommended for grant of permission to conduct the BA study as per protocol presented and results of BA study should be presented before the committee.

The committee also recommended that the firm should also conduct clinical trial in Indian patient for which protocol should be submitted.

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