Home HEALTH Wockhardt gets favourable recommendation from CDSCO for antibiotic for CABP

Wockhardt gets favourable recommendation from CDSCO for antibiotic for CABP

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Drug firm Wockhardt on Friday said the national drug regulator has accorded a favourable recommendation for its novel antibiotic developed for the treatment of community-acquired bacterial pneumonia (CABP) in adults. The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) has provided a favourable recommendation for Miqnaf (nafithromycin), the drug firm said in a statement.

The SEC recommendation is based on CDSCO’s comprehensive review of the product dossier consisting of non-clinical, US/EU Phase 1, Global Phase 2 and India Phase 3 clinical studies conducted over the last 15 years, it added.

A positive opinion from the SEC of CDSCO would pave the way for gaining DCGI’s final approval for Miqnaf, the company stated.

Miqnaf is the once-a-day 3-days-only treatment for CABP patients, including those caused by multi-drug resistant (MDR) bugs.

CABP is the most common infection, leading to hospitalisation and death. Globally, 2.4 million annual deaths are caused by lower respiratory tract infections.

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India contributes to 23 per cent of the global community pneumonia burden, the drug firm said. Wockhardt shares on Friday ended 5 per cent up at Rs 994.95 apiece on BSE.

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