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Miqnaf is an ultra-short course, once-a-day, three-day treatment for CABP, including infections caused by multi-drug resistant (MDR) pathogens. The approval follows a positive recommendation from the Subject Expert Committee (SEC) of CDSCO to manufacture and market nafithromycin.
Over 15 years, Miqnaf underwent extensive non-clinical and clinical studies, including human trials in the US, Europe, South Africa and India. It represents a new macrolide-based treatment for CABP in India after a gap of nearly 30 years.
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Moreover, the ultra-short course regimen is said to enhance patients’ compliance with treatment, resulting in favourable outcomes. In India, antibiotic resistance is a burning issue, including in community pneumonia cases.
A key strength of Miqnaf is its ability to target a wide range of respiratory infections, including bacteria resistant to common antibiotics like azithromycin and amoxicillin/clavulanate, making it a strong single-treatment option for pneumonia.
CABP affects millions of people worldwide, with 23% of the global disease burden borne by India. Several bacterial pathogens could cause CABP and other respiratory infections, the dominant being S. pneumoniae and H. influenzae and atypical respiratory pathogens such as Mycoplasma, Chlamydia and Legionella.
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Miqnaf is designed to obviate the need for such hospitalisation. Wockhardt plans to launch Miqnaf in the Indian market in the coming few months. Shares of Wockhardt Ltd ended at ₹1,445.75, down by ₹12.80, or 0.88% on the BSE.
