Zydus Healthcare gets CDSCO panel nod to manufacture, market Indacaterol, Budesonide Inhaler

This came after the firm presented Phase-III clinical trial report of the respiratory drug combination Indacaterol maleate (75mcg) plus Budesonide IP (200mcg) Inhaler before the committee.

Earlier, the Medical Dialogues Team had reported that the Central Drugs Standard Control Organization (CDSCO) had granted permission to Zydus Healthcare to conduct the Phase III study of the respiratory drug combination Indacaterol maleate plus Budesonide dry powder for inhalation and inhaler. However, the permission came with the condition that the survey should include more government sites.

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 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. Indacaterol also has a high intrinsic efficacy so it is also very rapid acting - onset of action occurs within 5 minutes.

The European Medicines Agency (EMA) approved Indacaterol on November 30, 2009, and the Food and Drug Administration (FDA) approved it on July 1, 2011. In Europe, it's marketed as Onbrez, while in the United States, it's marketed as Arcapta Neohaler. The maleate salt form of indacaterol is offered.

Budesonide is a glucocorticoid that is a mix of the 22R and 22S epimer used to treat inflammatory conditions of the lungs and intestines such as asthma, COPD, Crohn's disease, and ulcerative colitis.

The committee at its latest SEC meeting for Pulmonary thoroughly examined the Phase-III clinical trial (CT) report of respiratory drug combination Indacaterol maleate (75mcg) plus Budesonide IP (200mcg) Inhaler presented by Zydus Healthcare.

After detailed deliberation, the committee recommended the grant of permission to manufacture and market the proposed fixed dose combination (FDC).