The Central Drugs Standard Control Organization (CDSCO) has granted approval to Wockhardt's Miqnaf (Nafithromycin), a new generation oral antibiotic, for the treatment of community-acquired bacterial pneumonia (CABP) in adults. This approval marks a significant advancement in addressing antibiotic resistance and improving treatment compliance for CABP patients in India.
A Novel Macrolide for CABP
Miqnaf (Nafithromycin) is a macrolide-based antibiotic designed for an ultra-short, once-a-day, three-day treatment regimen. This abbreviated course aims to enhance patient compliance and improve treatment outcomes, particularly in cases involving multi-drug resistant (MDR) pathogens. The approval was based on the favorable recommendation from the Subject Expert Committee (SEC) of the CDSCO, following extensive non-clinical and clinical studies conducted over 15 years in the U.S., Europe, South Africa, and India.
Addressing Antibiotic Resistance and Hospitalization
CABP affects millions globally, with India bearing 23% of the worldwide disease burden. Current oral antibiotics, such as azithromycin, face increasing resistance, while amoxicillin/clavulanate lacks coverage against atypical pathogens. This often necessitates hospitalization for intravenous treatment, increasing the risk of hospital-acquired infections and associated costs. Miqnaf is designed to circumvent the need for hospitalization by providing coverage against a broad spectrum of community respiratory pathogens, including pneumococci resistant to azithromycin and amoxicillin/clavulanate.
Clinical Significance and Future Availability
Miqnaf represents a new macrolide treatment option for CABP in India after nearly three decades. Its key feature is its comprehensive coverage of community respiratory pathogens, positioning it as a promising monotherapy. Wockhardt plans to launch Miqnaf in the Indian market in the coming months, offering a potentially safer, faster, and more tolerable solution for patients.
The development of Nafithromycin involved 14 years of research and an investment of ₹500 crore, supported by the Biotechnology Industry Research Assistance Council (BIRAC) under its Biotechnology Industry Partnership Programme.
