Wockhardt Ltd's shares gained after the U.S. drug regulator agreed to abridged clinical trials for phase III of its antibiotic.
This will allow the company to skip the second phase of trials, Wockhardt said in a stock exchange filing on Monday. The U.S. Food and Drug Administrator's (U.S. FDA) decision was based on evaluation of preclinical and clinical data of phase I to determine safety and and efficacy of the drug, the filing added.
The antibiotic WCK 5222 is a combination of two drugs ā Zidebactum and Cefepime ā and addresses threats of multi-drug resistant bacterias such as hospital acquired pneumonia and blood stream infections.
Wockhardt expects to launch the drug globally by the financial year 2020-21.
Shares of the drugmaker rose as much as 4.3 percent to Rs 750 are the announcement. The stock fell 4.4 percent in March while the Sensex rose 3.3 percent over the month.
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