Drug Approval & Key Details
- Drug Name: Miqnaf (Nafithromycin)
- Approved By: Central Drugs Standard Control Organization (CDSCO)
- Indication: Treatment of Community-Acquired Bacterial Pneumonia (CABP) in adults
- Manufacturer: Wockhardt
- Dosage: Ultra-short course, once-a-day for 3 days
- Launch Timeline: To be launched in India in the coming months
In a significant stride for India’s pharmaceutical and healthcare sectors, Miqnaf (Nafithromycin), developed by Wockhardt, has been approved by the Central Drugs Standard Control Organization (CDSCO) for the treatment of Community-Acquired Bacterial Pneumonia (CABP) in adults. This approval marks the first new macrolide-based treatment for CABP in India in nearly 30 years, addressing the growing challenge of antibiotic resistance and offering a promising solution for one of the country’s most pressing health concerns.
What is Miqnaf (Nafithromycin)?
Miqnaf is a novel macrolide antibiotic specifically designed to treat CABP, including infections caused by multi-drug resistant (MDR) pathogens. Its ultra-short course of once-a-day dosing for just three days sets it apart from existing treatments, offering a convenient and effective option for patients.
Key Features and Advantages
- Broad-Spectrum Efficacy:
- Effective against all major CABP pathogens, including S. pneumoniae, H. influenzae, and atypical pathogens like Mycoplasma, Chlamydia, and Legionella.
- Demonstrates bactericidal activity, high lung penetration, and a prolonged post-antibiotic effect, ensuring effective pathogen clearance.
- Short Treatment Duration:
- The 3-day, once-daily regimen improves patient compliance and reduces the risk of incomplete treatment, a common issue with longer courses.
- Safety and Tolerability:
- Unlike fluoroquinolones, which carry risks of severe side effects such as tendonitis, neuropathy, and cardiac issues, Nafithromycin is well-tolerated across age groups, including the elderly.
- It does not require combination therapy, making it a safer and more convenient alternative.
- Addressing Antibiotic Resistance:
- Effective against pathogens resistant to commonly used antibiotics like azithromycin and amoxicillin/clavulanate.
- Avoids concerns related to the selection of resistant Mycobacterium tuberculosis strains, a critical advantage in India’s TB-endemic setting.
- Potential to Reduce Hospitalizations:
- By providing effective oral monotherapy, Miqnaf can potentially reduce the need for hospitalization and intravenous treatments, lowering healthcare costs and the risk of hospital-acquired infections.
Development and Approval Journey
- Research and Trials:
- Nafithromycin underwent 15+ years of extensive non-clinical and clinical studies, including human trials in the US, Europe, South Africa, and India.
- The Phase III trial was partly supported by the Biotechnology Industry Research Assistance Council (BIRAC), which provided financial assistance of ₹9.18 crore.
- Regulatory Approval:
- On 1st January 2025, Nafithromycin tablets (400 mg) were approved under the New Drugs and Clinical Trials Rules, 2019, for the treatment of CABP in adults.
- The approval followed a favorable recommendation from the Subject Expert Committee (SEC) of CDSCO.
- Manufacturing and Distribution:
- Initially, the drug will be supplied only to medical colleges, tertiary care hospitals, and district hospitals.
- As a patented drug, Nafithromycin is eligible for incentives under the Production Linked Incentive (PLI) Scheme for Pharmaceuticals, which offers a 10% incentive on sales to promote domestic manufacturing.
The Burden of CABP in India
- CABP accounts for 23% of the global disease burden, with India being a significant contributor.
- Common pathogens like S. pneumoniae and H. influenzae, along with atypical pathogens, pose a growing challenge due to increasing antibiotic resistance.
- Existing treatments like azithromycin and amoxicillin/clavulanate face limitations, often necessitating hospitalization for intravenous therapy.
Pricing and Accessibility
- As a non-scheduled drug, the pricing of Nafithromycin is governed by the Drugs (Prices Control) Order, 2013.
- Manufacturers can set the maximum retail price (MRP), with a cap of 10% annual increase.
- Wockhardt plans to launch Miqnaf in India within the next few months, making it accessible to patients in need.
Future Implications
- Combating Antibiotic Resistance:
- Miqnaf’s ability to tackle MDR pathogens positions it as a critical tool in the global fight against antibiotic resistance.
- Economic and Healthcare Benefits:
- By reducing hospitalizations, Miqnaf can lower healthcare costs and alleviate the burden on India’s healthcare infrastructure.
- Boost for Domestic Pharma:
- The development and manufacturing of Nafithromycin align with India’s Atmanirbhar Bharat initiative, showcasing the country’s capability to innovate and produce cutting-edge drugs.
Miqnaf (Nafithromycin) represents a paradigm shift in the treatment of CABP, offering a potent, safe, and patient-friendly alternative to existing therapies. Its approval not only addresses a critical healthcare need but also underscores India’s growing prowess in pharmaceutical innovation. As Wockhardt prepares to launch this groundbreaking drug, the hope is that Miqnaf will transform the lives of millions of patients, reduce the burden of antibiotic resistance, and set a new standard for respiratory infection treatment worldwide.
Reference : Express Pharma
