Lupin Limited (Lupin) announced the launch of a novel fixed-dose triple drug combination (FDC) of Indacaterol, Glycopyrronium and Mometasone for managing inadequately controlled asthma amongst patients. The company has launched this important product under the brand name DIFIZMA® in India. Lupin is the first company in India to offer this novel FDC dry powder inhalation (DPI) product combining Indacaterol, a long-acting beta-agonist, Glycopyrronium, a long-acting muscarinic receptor antagonist, and Mometasone Furoate, an inhaled corticosteroid.

DIFIZMA® is the only FDC that has been approved by the Drug Controller General of India (DCGI) for the treatment of inadequately controlled Asthma. DIFIZMA® will help in the management of inadequately controlled asthma by improving lung function, providing better symptom control and reducing exacerbations. The drug will be available in one strength with a fixed-dose to be taken once daily.

The estimated national burden of asthma in India is at 17.23 million with an overall prevalence of 2.05%. Out of this, approximately INR 3.0 million patients can be classified under "inadequately controlled". These are the patients who have uncontrolled symptoms and higher chances of exacerbations which may lead to hospitalization contributing to higher DALYs (Disability adjusted life years) in most patients.

The launch of DIFIZMA® aligns with Lupin's commitment to introducing novel inhalation products globally. In India, Lupin ranks #2 in the respiratory therapy area (IQVIA, MAT Nov. 2022) and this launch will further reinforce the company's presence in the segment.