The Indian drug regulator, Central Drugs Standard Control Organization (CDSCO) has approved Miqnaf (nafithromycin) as a new treatment for the Community-Acquired Bacterial Pneumonia (CABP) in Adults. Miqnaf is an ultra-short course, once-a-day, 3-day treatment for CABP including those caused by multi-drug resistant (MDR) pathogens. The approval follows a favourable recommendation for manufacture and marketing of Nafithromycin from the Subject Expert Committee (SEC) of CDSCO.

Over >15 years, Miqnaf underwent extensive non-clinical and clinical studies which include human trials in U.S, Europe, South Africa and India. It represents a new macrolide based treatment for CABP in India almost after a gap of 30 years. Moreover, the ultra-short course regimen enhances the patients’ compliance to treatment resulting in favourable outcome. In India, antibiotic resistance is a burning issue including in community pneumonia cases.

A key feature of Miqnaf is its coverage of entire range of community respiratory pathogens including pneumococci resistant to azithromycin and amoxicillin/clavulanate, making it a promising monotherapy option for community-acquired bacterial pneumonia.

CABP affects millions of people worldwide with 23% of the global disease burden borne by India. CABP and other respiratory infections could be caused by several bacterial pathogens, the dominant being S. pneumoniae and H. influenzae and also by atypical respiratory pathogens such as Mycoplasma, Chlaymydia and Legionella.

The current oral antibiotics such as azithromycin face significant resistance challenges, while amoxicillin/clavulanate lack the coverage of atypicals, as a result, patients often require hospitalization to take intravenous treatment, which enhances the risk of hospital-acquired infections and imposes higher cost. Miqnaf is designed to obviate the need of such hospitalization.

Wockhardt plans to launch Miqnaf in the Indian market in coming few months.