During its 9th meeting on October 7, 2024, at CDSCO Headquarters in New Delhi, the Subject Expert Committee (Investigational New Drugs) granted Wockhardt Limited the rights to manufacture and market Nafithromycin (400 mg) under the brand name Miqnaf[1]. A recent report by Business Standard [2] corroborated this information.
The drug is approved for use for the treatment of adults (>18 years of age) with severe infections such as community-acquired bacterial pneumonia (CABP) and mild-to moderate infections such as acute bacterial exacerbations of chronic bronchitis (AECB), acute bacterial sinusitis and pharyngitis/tonsillitis caused by the susceptible microorganisms
CABP is a respiratory infection caused by bacterial infectious agents such as Streptococcus Pneumoniae. Other emerging causative agents are gram negative bacteria like Burkholderia, Mycoplasma pneumoniae, Pseudomonas aeruginosa and Klebsiella pneumoniae.
India accounts for 23% of the global burden of pneumonia with case fatality rates between 14 and 30 percent [3].
Symptoms of the disease include cough, breathlessness and fever but many individuals face variable nonspecific symptoms which can lead to potential delay in diagnosis. Early diagnosis and early management of the condition are key factors that decide the prognosis in a patient. Proper history taking, looking for appropriate clinical signs and investigations like chest Xray and clinical lab markers aid in early and correct diagnosis. Starting antibiotics early on and completing a full course is essential for management of disease and prevention of drug resistance.
Current treatment guidelines for pneumonia include the use of Beta-Lactams, Macrolides and Fluoroquinolones according to the patient characteristics. Preclinical studies have shown that nafithromycin is effective against macrolide and ketolide resistant strains of Streptococcus pneumoniae, as well as other respiratory pathogens such as Haemophilus influenzae, Moraxella catarrhalis, methicillin-susceptible Staphylococcus aureus, and group A streptococci [4].
A positive opinion from the Subject Expert Committee of CDSCO would pave the way for gaining Drugs Controller General of India's (DCGI) final approval for Miqnaf, the company stated.
As a novel antibiotic with action against multidrug-resistant (MDR) bacteria, nafithromycin presents a promising option in the evolving landscape of pneumonia treatment. However, further clinical studies are necessary to fully assess its efficacy and safety in diverse patient populations.
[1] cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/common_download.jsp?num_id_pk=MjM4MQ==
[2] https://doi.org/10.4103/ijmr.IJMR_1678_19
[3] https://doi.org/10.1128/AAC.01253-19
(Input from various sources)
(Rehash/Dr. Chhavi Garg/MSM)
