The Indian drug regulatory authority, Central Drugs Standard Control Organization (CDSCO), has authorized Miqnaf (nafithromycin) as a new treatment for Community-Acquired Bacterial Pneumonia (CABP) in adults. Miqnaf is a rapid, three-day treatment course administered once daily for CABP, including cases due to multi-drug resistant (MDR) pathogens. The endorsement comes after a positive recommendation for the production and sale of Nafithromycin from the Subject Expert Committee (SEC) of CDSCO.
For more than 15 years, Miqnaf has gone through comprehensive non-clinical and clinical research, including human trials conducted in the U.S., Europe, South Africa, and India. It signifies a new macrolide-based therapy for CABP in India, nearly three decades later. Additionally, the ultra-short course schedule improves patients’ adherence to treatment, leading to positive results. In India, antibiotic resistance is a critical problem, especially in cases of community pneumonia.
A significant aspect of Miqnaf is its extensive coverage of all community respiratory pathogens, including pneumococci that are resistant to azithromycin and amoxicillin/clavulanate, which positions it as a viable monotherapy choice for bacterial pneumonia acquired in the community.
CABP impacts millions globally, with India shouldering 23% of the worldwide disease burden. CABP and various respiratory infections may be triggered by multiple bacterial pathogens, primarily S. pneumoniae and H. influenzae, along with atypical respiratory pathogens like Mycoplasma, Chlamydia, and Legionella.
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