CDSCO approves Wockhardt’s drug Miqnaf to treat CABP in adults

Drugmaker Wockhardt on Thursday announced Central Drugs Standard Control Organization (CDSCO) approval for use of its new generation oral antibiotic Miqnaf (Nafithromycin) in the treatment of community-acquired bacterial pneumonia (CABP) in adults.

Miqnaf is an ultra-short course, once-a-day, three-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 of the CDSCO. The company plans to launch Miqnaf in the Indian market in coming few months, Wockhardt said in a release.

The drug represents a new macrolide based treatment for CABP in India almost after a gap of 30 years. The ultra-short course regimen enhances patients compliance to treatment resulting in favourable outcome. Miqnaf has underwent extensive non-clinical and clinical studies, including human trials in the U.S, Europe, South Africa and India, for over 15 years.

Miqnaf is designed to obviate the need for hospitalisation. CABP affects millions of people worldwide with 23% of the global disease burden borne by India. The current oral antibiotics such as azithromycin face significant resistance challenges, while amoxicillin/clavulanate lack the coverage of atypicals thus often requiring hospitalisation of the patients to take intravenous treatment.

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, it said.

In November, Union Minister Jitendra Singh had formally launched Nafithromycin, the first indigenous antibiotic for resistant infections, developed by Wockhardt with support from the Biotechnology Industry Research Assistance Council (BIRAC). The drug is ten times more effective than current options and offers a safer, faster, and more tolerable solution for patients, the government had then said.

The development of Nafithromycin represents 14 years of dedicated research and an investment of ₹500 crore, with clinical trials spanning the U.S., Europe, and India. Supported by BIRAC under its Biotechnology Industry Partnership Programme, the initiative showcases the power of public-private collaboration in advancing healthcare innovation, the Minister said.