Global pharma major Lupin Limited on Thursday 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.
According to the company’s statement, 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, the company stated.
According to the pharma major, 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 17.23 million with an overall prevalence of 2.05%. Out of this, approximately 30 lakh patients can be classified as “inadequately controlled”.
Studies show that these are the patients who have uncontrolled symptoms and higher chances of exacerbations which may lead to hospitalization contributing to higher Disability-adjusted life years (DALYs) in most patients.
“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,” Rajeev Sibal, President – India Region Formulations, Lupin said in a statement.
The company claims that 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,” it added.