USFDA okays abridged clinical trial for antibiotic: Wockhardt

By: | Published: April 3, 2017 4:33 PM

Drug firm Wockhardt today said the US health regulator has agreed to abridged clinical trials for an antibiotic being developed by the company.

The decision was based on the evaluation by 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. (Reuters)

Drug firm Wockhardt today said the US health regulator has agreed to 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 to abridged clinical trial for phase III for Wockhardt’s superdrug antibiotic WCK 5222,” the company said in a filing to BSE.

The decision was based on the evaluation by 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.

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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 the year 2020-2021, Wockhardt said. The Wockhardt stock was trading at Rs 767.50, up 6.60 per cent, in the afternoon on BSE.

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