Wockhardt’s antibiotic Miqnaf recommended by CDSCO

Indian drugmaker Wockhardt’s (BSE: 532300) today announced that the Subject Expert Committee (SEC) of Indian drug regulator, Central Drugs Standard Control Organization (CDSCO) has provided a favorable recommendation for its novel antibiotic Miqnaf (nafithromycin) discovered and developed for the treatment of community-acquired bacterial pneumonia (CABP) in adults.

Wockhardt, whose shares rose 5% to 1,046.55 rupees on the news, said that the SEC recommendation is based on CDSCO’s comprehensive review of product dossier consisting of non-clinical, US/EU Phase I, Global Phase II and India Phase III clinical studies conducted over the last 15 years. A positive opinion from SEC of CDSCO would pave the way for gaining DCGI’s final approval for Miqnaf.

According to the company, Miqnaf is globally, first-ever, once-a-day (OD) 3-days-only treatment for CABP patients including those caused by multi-drug resistant (MDR) bugs. The attractive feature of Miqnaf is that it is highly active against azithromycin and amoxicillin/clavulanate resistant Pneumococci, as well as entire range of pathogens involved in such infections and thus offering a monotherapy option.