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  • Miqnaf: CDSCO nod to...

Miqnaf: CDSCO nod to Wockhardt 3-day treatment for Community-Acquired Bacterial Pneumonia

Written By : Ruchika Sharma |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2025-01-03T16:40:08+05:30  |  Updated On 3 Jan 2025 4:40 PM IST
CDSCO nod to Wockhardt 3-day treatment for Community-Acquired Bacterial Pneumonia
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Mumbai: The Indian drug regulator, Central Drugs Standard Control Organization (CDSCO) has approved Miqnaf(nafithromycin) as a new treatment for the Community-Acquired Bacterial Pneumonia (CABP) in Adults.

Miqnaf is an ultra-short course, once-a-day, 3-day treatment for CABP including those caused by multi-drug resistant (MDR) pathogens.

The approval follows a favourable recommendation for manufacture and marketing of Nafithromycin from the Subject Expert Committee (SEC) of CDSCO.

Over >15 years, Miqnaf underwent extensive non-clinical and clinical studies which include human trials in U.S, Europe, South Africa and India. It represents a new macrolide based treatment for CABP in India almost after a gap of 30 years.

Moreover, the ultra-short course regimen enhances the patients’ compliance to treatment resulting in favourable outcome. In India, antibiotic resistance is a burning issue including in community pneumonia cases. A key feature of Miqnaf is its coverage of entire range of community respiratory pathogens including pneumococci resistant to azithromycin and amoxicillin/clavulanate.

Read also: Wockhardt group Founder Chairman Dr Habil Khorakiwala bags Lifetime Achievement Award at 10th IHW summit in Dubai

CABP affects millions of people worldwide with 23% of the global disease burden borne by India. CABP and other respiratory infections could be caused by several bacterial pathogens, the dominant being S. pneumoniae and H. influenzae and also by atypical respiratory pathogens such as Mycoplasma, Chlaymydia and Legionella.

The current oral antibiotics such as azithromycin face significant resistance challenges, while amoxicillin/clavulanate lack the coverage of atypicals, as a result, patients often require hospitalization to take intravenous treatment, which enhances the risk of hospital-acquired infections and imposes higher cost. Miqnaf is designed to obviate the need of such hospitalization, claimed Wockhardt.

Wockhardt plans to launch Miqnaf in the Indian market in coming few months.

Wockhardt has a portfolio of 6 products at various stages of clinical development and commercialization, each of which have been granted Qualified Infectious Disease Product status by the US FDA.

Read also: Wockhardt Founder Seeks GST Exemption on India-Discovered Antibiotics to Enhance Affordability

CDSCOmiqnafnafithromycincommunity acquired bacterial pneumonia
Ruchika Sharma
Ruchika Sharma

    Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

    Dr. Kamal Kant Kohli
    Dr. Kamal Kant Kohli

    Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751

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