In a significant development, Mumbai-based pharmaceutical company Wockhardt has introduced nafithromycin, a new drug designed to treat community-acquired bacterial pneumonia (CABP). This drug is being hailed as a powerful alternative to existing antibiotics, such as azithromycin, which is facing rising resistance in humans.
Nafithromycin, branded as Miqnaf, is part of India’s ongoing efforts to address the growing challenge of antimicrobial resistance (AMR). According to recent studies, the drug has shown a 96.7% clinical cure rate, a significant improvement over current treatments. Furthermore, it demonstrates eight times the lung exposure and ten times the potency of azithromycin, making it a more effective option for patients battling bacterial infections.
In addition to its enhanced efficacy, nafithromycin is expected to result in fewer side effects and drug interactions, providing a safer treatment option for those affected by CABP. The drug has undergone 14 years of development, with an investment of Rs 500 crore. Its development has also been supported by the Biotechnology Industry Research Assistance Council (BIRAC), which provided both technical and financial backing.
Currently, nafithromycin is awaiting final approval from the Central Drugs Standard Control Organisation (CDSCO) for manufacturing. The drug is expected to be commercially available by late 2025. To ensure broader accessibility, the Indian government plans to include nafithromycin in the Ayushman Bharat scheme, which will make it more affordable for patients.
While nafithromycin is a groundbreaking achievement, it is not the first antimicrobial resistance (AMR) treatment to be developed in India. Earlier this year, Chennai-based Orchid Pharma received approval from the U.S. Food and Drug Administration (FDA) for enmetazobactam, a drug designed to treat complicated urinary tract infections (UTIs). Unlike traditional antibiotics, enmetazobactam targets bacterial defense mechanisms without triggering resistance, preserving the effectiveness of carbapenems—the last-resort antibiotics for severe infections.
The development of both nafithromycin and enmetazobactam underscores India’s growing role in addressing global antibiotic resistance through innovation and research.
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