NEW DRUG DISCOVERY
EMROK
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MIQNAF
FOVISCU
ZAYNICH
Zaynich (zidebactam/cefepime 1 g/2 g IV, thrice-daily) a combination of zidebactam and cefepime, is Wockhardt’s novel patented antibiotic, targeted towards multi-drug resistant Gram-negative infections which has been granted Qualified Infectious Disease Product status by the US FDA. It has successfully completed Phase 3 study and has received regulatory approval from the United States Food and Drug Administration (US FDA) and the Central Drugs Standard Control Organisation (CDSCO), India. In parallel, the Marketing Authorisation Application (MAA) for Zaynich is under review by the European Medicines Agency (EMA). Earlier, multiple Phase I studies including clinical pharmacology studies with Zidebactam/Cefepime were conducted in US. Zaynich completed Phase II study in India for the treatment of documented carbapenem-resistant infections. Clinical and Laboratory Standards Institute (CLSI) has endorsed a high investigational susceptibility breakpoints of ≤ 64 mg/L to Zaynich which is suggestive of its strong potential to comprehensively cover clinically important, extreme drug resistant Gram negative pathogens in seriously ill patients. Under compassionate use, Zaynich, has successfully treated over 80 seriously ill patients in India and US who were suffering from extreme drug-resistant infections and did not respond to any of the available treatment options.
