Approved Pneumonia Medications by CDSCO and US FDA to Alleviate Public Health Burden

Indian healthcare professionals find relief with the accessibility of newly sanctioned medications designed to treat the severe respiratory illness, pneumonia. These treatments target hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP), prevalent in Indian hospitals, where the lack of innovative drugs often results in patient fatalities. These pneumonias are typically caused by a diverse range of bacteria from patient flora or within the hospital setting.

Celebrated as a groundbreaking development, India’s premiere indigenous antibiotic to combat antimicrobial resistance (AMR), Nafithromycin, is developed with aid from the Biotechnology Industry Research Assistance Council (BIRAC). Marketed by Wockhardt under the brand name ‘Miqnaf,’ it marks a significant achievement.

Earlier, the US FDA granted approval for Xacduro, a combination of sulbactam and durlobactam, designed for conditions involving hospital-acquired or ventilator-associated pneumonia. These occur in patients aged 18 and over, especially when caused by the Acinetobacter baumannii-calcoaceticus complex.

Following Covid, immense strides have been made in researching infectious diseases due to their deadly nature. Drug-resistant pneumonia contributes to over two million deaths worldwide annually, with 1 in 31 Indian in-patients daily diagnosed with a respiratory hospital-acquired infection.

Dr. Sunil Kumar K, lead consultant in interventional pulmonology at Aster CMI Hospital, emphasizes the importance of this US FDA approval amid rising global antimicrobial resistance, specifically targeting multidrug-resistant pneumonia, including Klebsiella pneumoniae. Given the severe public health challenge posed by drug-resistant infections in India, the drug shows potential for enhancing outcomes, notably in intensive care units confronting pneumonia from resistant bacteria.

Pneumonia, characterized by lung inflammation, commonly arises from bacterial, viral, or fungal sources. This results in air sacs filling with fluid or pus, hampering oxygen exchange. Symptoms include coughing, fever, chills, breathing difficulties, chest pain, and fatigue. Risk groups include the elderly, children, smokers, and those with compromised immunity, Dr. Kumar noted.

Diagnosis involves physical assessments, chest x-rays, blood tests, and sputum examinations to identify the causative bacteria. Treatment is contingent on the infection type, with bacterial pneumonia requiring antibiotics, while other forms necessitate antiviral or antifungal treatments, Dr. Kumar explained.

Implementing these cutting-edge treatments in India will necessitate regulatory approvals and consideration of costs. Nevertheless, the medication underscores India’s fight against antimicrobial resistance, promising to save lives and lessen healthcare burdens, Dr. Kumar conveyed to Pharmabiz via email.

Similarly, Dr. Vivek Anand Padegal, pulmonology director at Fortis Hospital, observed that rampant Acinetobacter infections, especially those resistant to multiple drugs, are a growing concern globally, including in India. This bacterium’s resistance to existing antibiotics often leads to failed treatments, longer hospital stays, and increased mortality.

To confront this, the novel drug combination Xacduro has been developed, merging durolobactam and sulbactam. Durolobactam prevents beta-lactamase activity, while sulbactam both inhibits beta-lactamase and acts as an antibiotic on its own, he elaborated.

Xacduro targets infections linked with the Acinetobacter baumannii-calcoaceticus complex, such as hospital-acquired and ventilator-associated pneumonia. These can drastically worsen patient prognoses and lengthen hospital stays, increasing mortality.

Dr. Padegal highlights Xacduro as a promising new option for managing select cases of this severe infection, providing an essential addition in the battle against multidrug-resistant Acinetobacter infections.