Shares of Wockhardt are higher by 5% on January 3 after Indian drug regulator approved oral antibiotic for the treatment of Pneumonia, the company informed in an exchange filing.
Central Drugs Standard Control Organization (CDSCO) approved antibiotic Nafithromycin, sold under Miqnaf brand, as a new treatment for community-acquired bacterial Pneumonia (CABP) in adults. The treatment also includes Pneumonia caused by multi-drug resistant (MDR) pathogens. Wockhardt's Miqnaf is an ultra-short course, once-a-day, for a three-day treatment.
With the approval coming through, Wockhardt said it plans to launch Miqnaf in the Indian market in coming few months.
Antibiotic resistance is a very significant issue in India, including in cases of community pneumonia (CABP). One of thw features of Miqnaf, Wockhardt said, is its coverage of entire community respiratory pathogens, which makes it a promising monotherapy option for CABP. Wockhardt said for Miqnaf has undergone extensive non-clinical and clinical studies for more than 15 years, including human trials in US, Europe, South Africa and India.
"...the ultra-short course regimen enhances the patients’ compliance to treatment resulting in favourable outcome," said the company statement.
Wockhardt claims current oral antibiotics such as azithromycin 'face significant resistance challenges', and amoxicillin lacks the coverage of atypicals, leading patients to often need hospitalization and intravenous treatment. Miqnaf is designed to 'obviate the need of such hospitalization,' said Wockhardt.
CABP affects millions worldwide, but 23% of the disease burden is borne by India.
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