Wockhardt's Novel Antibiotic Miqnaf™ Receives Favourable Recommendation for CABP Treatment

Wockhardt's novel antibiotic, Miqnaf™ (Nafithromycin), has received a favourable recommendation from the Subject Expert Committee of the Central Drugs Standard Control Organization (CDSCO) for the treatment of Community-Acquired Bacterial Pneumonia (CABP) in adults. The recommendation is based on a comprehensive review of non-clinical, US/EU Phase 1, Global Phase 2, and India Phase 3 clinical studies conducted over the last 15 years. Miqnaf™ is a once-a-day, 3-days-only treatment for CABP patients, including those caused by multi-drug resistant (MDR) bugs. It is highly active against azithromycin and amoxicillin/clavulanate resistant Pneumococci, and the entire range of pathogens involved in such infections, offering a monotherapy option. A lung penetration study conducted in the US demonstrated best-in-class lung concentrations of Miqnaf™, enabling a convenient, compliance-friendly treatment for respiratory infections. Miqnaf™ is expected to play a significant role in offering a reliable treatment option in the community, thus obviating the need for hospitalization. Community-acquired pneumonia is the most common infection leading to hospitalization and deaths. Children and older adults are particularly vulnerable. Globally, 2.4 million annual deaths are caused by lower respiratory tract infections. India contributes to 23% of the global community pneumonia burden. Wockhardt's new drug discovery portfolio has resulted in a portfolio of 6 products at various stages of clinical development and commercialization, each of which have been granted Qualified Infectious Disease Product status by the US FDA.