The Central Drugs Standard Control Organisation (CDSCO) has provided a favorable recommendation for Wockhardt's novel antibiotic, Miqnaf (nafithromycin), for the treatment of community-acquired bacterial pneumonia (CABP) in adults. This decision marks a significant step toward a new treatment option for a common and potentially deadly infection.
The Subject Expert Committee (SEC) of the CDSCO based its recommendation on a thorough review of the drug's dossier. This included non-clinical studies, US/EU Phase 1 trials, global Phase 2 trials, and Phase 3 clinical studies conducted in India over the past 15 years. A positive opinion from the SEC paves the way for final approval from the Drugs Controller General of India (DCGI).
Miqnaf: A Novel Approach to CABP Treatment
Miqnaf offers a unique treatment regimen for CABP, involving a once-a-day dose for only three days. This simplified approach aims to improve patient compliance and convenience. Notably, Miqnaf has demonstrated effectiveness against multi-drug resistant (MDR) strains of bacteria, a growing concern in the treatment of respiratory infections. The drug is highly active against azithromycin and amoxicillin/clavulanate-resistant Pneumococci, as well as a broad spectrum of pathogens involved in CABP, offering a monotherapy option.
Clinical Significance and Impact
Community-acquired pneumonia is a leading cause of hospitalization and death worldwide. Globally, lower respiratory tract infections account for 2.4 million deaths annually. India contributes significantly to this burden, accounting for 23% of global community pneumonia cases. The availability of Miqnaf could significantly impact patient outcomes by providing a reliable and convenient treatment option, potentially reducing the need for hospitalization. A lung penetration study conducted in the US demonstrated best-in-class lung concentrations of Miqnaf.
Wockhardt's Stock Performance
Following the announcement, Wockhardt shares experienced a surge, reflecting investor confidence in the potential of Miqnaf. Wockhardt shares were locked in a 5 per cent upper circuit on BSE, at Rs 1044.65 per share, in Monday's trade.
