New Delhi: There is good news for clinicians and doctors struggling to save patients from infections by deadly bacteria—the soft launch of nafithromycin, India’s first indigenously developed antibiotic, last week.
Bacterial infections can lead to death in patients when pathogens no longer respond to existing antibiotics—a condition commonly called antimicrobial resistance or AMR.
Nafithromycin is effective against multiple drug-resistant pathogens, with Union Minister of Science and Technology Jitendra Singh calling it a breakthrough innovation in India’s fight against antimicrobial resistance.
Mumbai-based Wockhardt Limited developed Nafithromycin with the support of the Biotechnology Industry Research Assistance Council (BIRAC) under the Centre’s Department of Biotechnology (DBT).
The medicine will be available under the brand name Miqnaf.
It would treat community-acquired bacterial pneumonia (CABP), a lower respiratory tract infection, disproportionately affecting vulnerable populations, including children, the elderly and immunocompromised hosts such as patients with diabetes and cancers.
In phase 3 clinical trials, the medicine showed more than a 97 percent efficacy rate in treating pneumonia.
According to details shared by Wockhardt and the government, the drug paves the way for the first-ever once-a-day, three-day treatment for patients of CABP, including those caused by multi-drug resistant bugs.
Top functionaries in the government said the three-day treatment regimen could be a game-changer in addressing drug-resistant pneumonia, a condition responsible for over 24 lakh deaths globally each year.
The subject expert committee of the Central Drugs Standard Control Organisation (CDSCO), the apex drug regulator in India, has approved the drug for manufacturing and marketing. It is awaiting a formal nod by the Drug Controller General of India before hitting the market.
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Massive AMR challenge
According to government estimates, India bears 23 percent of the world’s community pneumonia burden or logs nearly 40 lakh cases a year, with case fatality rates between 14 and 30 percent. Children under five years and the elderly are the most affected.
The country, experts said, has been facing challenges with existing treatments, such as widespread resistance to drugs such as azithromycin, a commonly used antibiotic. Nearly 20-30 percent of CABP cases do not respond to oral antibiotics, forcing clinicians to recommend hospitalisation and subsequent administration of injectables for patients.
Some experts ThePrint spoke with underlined that the development of nafithromycin is significant, given the stagnation in approvals for new, wide-spectrum antibiotics since the late 1980s despite pneumonia leading to several million deaths annually worldwide.
“Antibiotics that are less effective lengthen the duration of illnesses and raise morbidity and mortality and lead to increased costs for healthcare due to the need for more diagnostic tests, second-line antibiotics, and longer hospital stays,” Dr Sunil Havannavar, internal medicine specialist with Manipal Hospitals in Bengaluru, pointed out.
He said that novel drugs to treat antibiotic-resistant diseases are crucial as innovative treatments aim to get around resistance mechanisms or combat bacterial infections in entirely different ways.
Took 14 years to develop
The discovery and development of nafithromycin spanned over 14 years. Before the late-stage trials of the drug in India, it completed multiple phase 1 studies and a global phase 2 trial in the US and Europe.
Nafithromycin belongs to a class of novel lactone ketolide or a semi-synthetic macrolide antibiotic that exhibits enhanced activity against multiple drug-resistant bacteria. The drug is designed for administration through an ultra-short—once-a-day, three-day—therapy because it can stay in the lungs for long durations.
Scientific evidence has shown that Streptococcus pneumoniae is the most common organism behind CABP, accounting for 33 percent of the cases, followed by Klebsiella pneumoniae (23 percent), Staphylococcus aureus (10 percent), and Mycoplasma pneumoniae and Legionella pneumophila accounting for seven percent of cases each.
However, two of the most common bacteria causing the illness—S pneumoniae and K pneumoniae—are fast becoming resistant to the existing antibiotics.
Nafithromycin belongs to a class of antibiotics called macrolide antibiotics, which treat various infections and have been found ten times more effective than azithromycin. Another remarkable feature is that the drug is highly active against azithromycin-, amoxicillin- or clavulanate-resistant S pneumoniae.
Beyond its efficacy, nafithromycin boasts superior safety and tolerability, said the government, adding that the antibiotic has minimal gastrointestinal side effects, no significant drug interactions, and remains unaffected by food, making it a versatile option for patients.
(Edited by Madhurita Goswami)
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