Zydus Healthcare gets CDSCO panel nod for study of Indacaterol, Budesonide inhaler
New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) has shown a green light 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 comes with the condition that the survey include more government sites.
The recommendation came in the wake of the proposal presented by the firm to conduct a Phase III clinical study of Indacaterol maleate eq. to Indacaterol 75mcg/150mcg plus Budesonide IP 200mcg/400mcg Dry Powder for Inhalation before the Committee. The company also presented a proposal for a Phase III clinical trial of an inhaler comprising Indacaterol maleate equivalent to Indacaterol 75mcg and Budesonide IP 200mcg.
Indacaterol is a long-acting β2-adrenoceptor agonist and bronchodilator with a rapid onset of action. It was developed by Novartis. It is used to relax bronchial smooth muscle and improve symptoms and airflow obstruction caused by Chronic Obstructive Pulmonary Disease (COPD) and moderate to severe asthma.
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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 acts as an anti-inflammatory and immunomodulator. Budesonide inhalation is a treatment for asthma and chronic obstructive pulmonary disease (COPD).
The committee at its latest SEC meeting for Pulmonary thoroughly examined Zydus Healthcare's proposal to conduct a phase 3 clinical trial of Indacaterol maleate eq. to Indacaterol 75mcg/150mcg plus Budesonide IP 200mcg/400mcg dry powder for inhalation and Indacaterol maleate eq. to Indacaterol 75mcg plus Budesonide IP 200mcg Inhaler.
Responding to both the proposals, after detailed deliberation, the committee recommended the grant of permission to conduct the Phase III study with the condition of adding more government sites to the study.
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