Miqnaf: CDSCO nod to Wockhardt 3-day treatment for Community-Acquired Bacterial Pneumonia
Mumbai: 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.
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