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Wockhardt has said the US health regulator has agreed for abridged clinical trials for an antibiotic being developed by the company.
“In a recent meeting between Wockhardt research team and USFDA new drug antibiotic regulatory team, USFDA agreed for abridged clinical trials for phase III of Wockhardt’s superdrug antibiotic WCK 5222,” the company said in a filing to the BSE today.
The decision was based on the evaluation by the United States Food and Drug Administration (USFDA) of its preclinical and clinical data of phase I establishing safety and clinical scope of efficacy for the drug, it added.
WCK 5222 is a combination of Zidebactam and Cefepime, Wockhardt said, adding that it is expected to be a life-saving therapy for serious hospital acquired infections such as pneumonia, ventilator associated pneumonia and blood stream infections.
The company expects global clinical launch of WCK 5222 during 2020-2021, Wockhardt said.
Wockhardt stock ended the session up by 6.28 per cent at Rs 765.25 on the BSE.
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