Glenmark drug for treating uncontrolled asthma gets Indian regulator's nod

Company says treatment will be affordable and improve lung function of patients

Mumbai-based Glenmark has got the Indian regulator’s approval for a drug to treat patients of uncontrolled asthma. The fixed dose combination (FDC) drug will be sold under the brand name Indamet.

An FDC drug combines two or more active ingredients into a single pill in a fixed dosage ratio. Indamet--a combination of Indacaterol and Mometasone--will be available in three strengths and it will be priced between Rs 349 and Rs 449.

"We are proud to introduce this novel fixed-dose combination Indamet, which is the first of its kind in India, offering an affordable treatment option to both adults and adolescents 12 years of age and older suffering from uncontrolled asthma," said Alok Malik, Glenmark Pharmaceuticals Group vice president and head (India Formulations), in a statement.

Asthma affects more than 34 million people in India, causing thousands of deaths every year. According to the Global Burden of Disease report by the Institute for Health Metrics and Evaluation (IHME), asthma accounted for 27.9 percent of disability-adjusted life years (DALYs) in Indians. The disease causes three times higher mortality and two times higher DALYs compared to the global proportion of asthma. Out of the patients undergoing conventional treatment in India, up to 49 per cent have uncontrolled asthma.

Indamet will help manage uncontrolled asthma by improving lung function, better symptom control and reducing exacerbations, said Glenmark.

India, in 2016, banned 344 FDCs saying that they had 'no therapeutic justification'. This was an attempt to weed out 'irrational' FDCs from the market.

Pharmaceutical companies applied to review some of their FDC drugs, as the ban is estimated to have had an impact of around Rs 4000 crore on the Indian pharma market. Ever since FDC approvals have been slow and reviewed closely.