Conduct bioequivalence study: CDSCO Panel Tells Lupin on FDC Indacaterol, Glycopyrronium inhalation powder
New Delhi: Rejecting the justification for the waiver of the bioequivalence study (BE) and Phase III clinical study of fixed-dose combination (FDC) Indacaterol Maleate plus Glycopyrronium bromide inhalation powder presented by the drug major Lupin, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the firm to conduct BE study as per the presented BE study protocol.
This came after the drug major Lupin presented its proposal along with justification for the BE waiver and Phase III CT waiver before the committee. Furthermore, the firm also presented the BE study protocol 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.
Indacaterol is used for the long-term maintenance treatment of airflow blockage in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. COPD is a long-term lung disease that causes bronchospasm (wheezing or difficulty with breathing). Indacaterol is a long-acting bronchodilator.
Indacaterol works by stimulating adrenergic beta-2 receptors in the smooth muscle of the airways. This causes relaxation of the muscle, thereby increasing the diameter of the airways, which become constricted in asthma and COPD. It is also long-acting due to its high affinity to the lipid raft domains in the airway membrane so it slowly dissociates from the receptors.
Glycopyrronium is an anticholinergic agent used to treat hyperhidrosis, severe drooling, and COPD, used with other medications to treat ulcers, and used in anesthesia.
Glycopyrrolate's primary mechanism of action is the blockage of acetylcholine's effects at the parasympathetic sites in various tissues. This blockage primarily occurs in the central nervous system, smooth muscle, and secretory glands. It also reduces the rate of salivation by preventing the stimulation of the acetylcholine receptors themselves.
At the recent SEC meeting for the Pulmonary held on 7th November 2023, the expert panel reviewed the proposal along with justification for the BE waiver and Phase III clinical trial waiver of the Pulmonary FDC Indacaterol Maleate plus Glycopyrronium bromide inhalation powder
After detailed deliberation, the committee did not consider the justification for the waiver of the BE study and Phase III CT study.
In accordance with the above, the expert panel recommended conducting the BE study as per the presented BE study protocol.
Furthermore, the committee suggested that the firm should submit the BE study report to CDSCO for further review by the committee.
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