Cipla gets CDSCO Panel nod to manufacture, market COPD drug combination Aerosol for inhalation
New Delhi: Granting the phase III clinical trial study waiver, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has given its nod to pharma major Cipla for manufacturing and marketing the fixed-dose combination drug, Budesonide 200 mcg plus Glycopyrronium 12.5 mcg plus Formoterol Fumarate Dihydrate Aerosol for inhalation for the treatment of chronic obstructive pulmonary disease (COPD). However, the approval was conditional on carrying out a Phase IV clinical trial study.
This was in line with the proposal presented by the pharma major Cipla for the fixed dose combination drug, Budesonide 200 mcg plus Glycopyrronium 12.5 mcg plus Formoterol Fumarate Dihydrate Aerosol for Inhalation, along with justification for a Phase III Clinical Trial (CT) study waiver.
Chronic obstructive pulmonary disease (COPD) is an inflammatory lung disease that is characterized by chronic airflow limitation and persistent respiratory symptoms. Budesonide/glycopyrronium bromide/formoterol fumarate is a fixed-dose combination (FDC) that has been approved in several countries for the maintenance treatment of COPD.
Budesonide is a corticosteroid used to treat Crohn's disease, asthma, COPD, hay fever, allergies, and ulcerative colitis. Budesonide is a potent topical anti-inflammatory agent. It binds and activates glucocorticoid receptors (GR) in the effector cell's (e.g., bronchial) cytoplasm, which allows the translocation of this budesonide-GR complex in the bronchial nucleus, which binds to both HDCA2 and CBP (HAT). This budesonide-CBP (HAT) receptor complex prevents the production of inflammatory genes (inhibition of gene transcription) that might cause bronchoconstriction.
Glycopyrronium is a muscarinic antagonist with the highest affinity for M1 receptors, followed by M3, M2/M4, and M5. It helps to prevent the formation of secretions that can cause problems in your respiratory tract.
Formoterol is an inhaled beta2-agonist used in the management of COPD and asthma. Formoterol works locally in the lungs as a bronchodilator, relaxing smooth muscle and opening up the airways.
At the recent SEC meeting for pulmonary held on November 4, 2022, the expert panel reviewed the proposal presented by the pharma major Cipla for the fixed dose combination drug, Budesonide 200 mcg plus Glycopyrronium 12.5 mcg plus Formoterol Fumarate Dihydrate Aerosol for inhalation, along with justification for a Phase III clinical trial (CT) study waiver.
After detailed deliberation, the committee recommended the grant of permission to manufacture and market the proposed fixed dose combination (FDC) with a condition to conduct the Phase IV CT study.
Furthermore, the expert panel directed that the protocol should be submitted to CDSCO within three months and presented before the committee for review.
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