Submit Supportive Documents for safety of Fluticasone dose: CDSCO panel Tells Glenmark on FDC pulmonary drug
New Delhi: Based on the Phase III clinical trial protocol and justification for the inhalation toxicity of the fixed-dose combination (FDC) pulmonary drug Glycopyrronium Bromide plus Fluticasone Furoate plus Vilanterol Trifenatate (50mcg/50mcg +100mcg/200mcg+25mcg/25mcg) Dry Powder for inhalation, the Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) has opined that the drug major Glenmark Pharmaceuticals should submit supportive documents/ scientific literature with respect to the safety of the dose of Fluticasone Furoate (200mcg) in three-drug combination in uncontrolled asthma.
This came after drug major Glenmark Pharmaceuticals presented its proposal along with Phase III clinical trial protocol and justification for inhalation toxicity study before the committee.
Glycopyrronium bromide belongs to a group of medicines called “anticholinergics”. These medicines help to prevent the formation of secretions that can cause problems in the respiratory tract. Glycopyrrolate, or glycopyrronium bromide inhibits parasympathetic nerve impulses by selectively blocking the binding of acetylcholine to muscarinic receptors.
Fluticasone is used to treat seasonal and year-round allergy symptoms such as stuffy/runny nose, itching, and sneezing. It may also reduce other symptoms of seasonal allergies such as red, itchy, and watery eyes.
The mechanism of action of corticosteroids, like fluticasone, works to inhibit inflammatory cells, such as mast cells, neutrophils, lymphocytes, and macrophages. Fluticasone helps to inhibit the secretion of histamines, cytokines, and leukotrienes which are commonly released with asthma and allergic responses.
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.
At the recent SEC meeting for Pulmonary held on 21st August 2023, the expert panel reviewed the proposal presented by the drug major Glenmark Pharmaceuticals, along with the Phase III clinical trial protocol and justification for inhalation toxicity of the FDC Glycopyrronium Bromide plus Fluticasone Furoate plus Vilanterol Trifenatate (50mcg/50mcg +100mcg/200mcg+25mcg/25mcg) Dry Powder for inhalation
After detailed deliberation, the committee opined that the firm should submit supportive documents/ scientific literature with respect to the safety of the dose of Fluticasone Furoate (200mcg) in a three-drug combination in uncontrolled asthma.
Accordingly, the expert panel suggested that the firm should submit the above data for further review by the committee.
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