CDSCO committee recommends Wockhardt’s novel antibiotic Miqnaf for CABP treatment

The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) has provided a recommendation for Wockhardt’s novel antibiotic Miqnaf (nafithromycin) for the treatment of Community-Acquired Bacterial Pneumonia (CABP) in adults. The SEC recommendation is based on a comprehensive review of the product dossier, which includes non-clinical, US/EU Phase 1, Global Phase 2, and India Phase 3 clinical studies conducted over the last 15 years. A positive opinion from the SEC of CDSCO would pave the way for gaining the final approval from the Drug Controller General of India (DCGI) for Miqnaf.

Miqnaf is reportedly the first-ever once-a-day, three-day treatment for CABP patients, including those with multi-drug resistant (MDR) infections. The product is highly active against azithromycin and amoxicillin/clavulanate-resistant Pneumococci, providing a monotherapy option against a range of pathogens involved in such infections. A lung penetration study conducted in the US demonstrated the best-in-class lung concentrations of Miqnaf, evolving a convenient and compliance-friendly treatment for respiratory infections.

Miqnaf is expected to play a significant role in offering a reliable treatment option in the community, thus potentially reducing the need for hospitalisation.