Global pharma major Lupin Limited has 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% and out of this, approximately 30 lakh 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.

Commenting on the launch, Rajeev Sibal, President – India Region Formulations, Lupin said, “We are excited about the launch of DIFIZMA, a first-of-its-kind novel combination product available in India. DIFIZMA is aimed at catering to the unmet need of patients with inadequately controlled asthma and aligns closely with Lupin’s ideology of patient-centricity and enabling accessibility for medicines.”

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.

Lupin is the third-largest pharmaceutical company in the US by prescription. The company invested 8.7% of its revenue in research and development in FY22. Lupin has 15 manufacturing sites, seven research centers, more than 20,000 professionals working globally, and has been consistently recognized as a ‘Great Place to Work’ in the Biotechnology & Pharmaceuticals sector.