FDA Agrees to Abridged Phase III Trial for Wockhardt Antibiotic
The FDA agreed to an abridged Phase III clinical trial for Wockhardt’s antibiotic WCK 5222.
This was based on evaluation of its preclinical and clinical data of a Phase I trial establishing safety and clinical scope of efficacy for the drug.
WCK 5222 is a combination of cefepime and zidebactam, a new drug developed by Wockhardt.
The FDA previously granted a fast track and a qualified infectious disease product designation for the drug. Wockhardt expects a global clinical launch of WCK 5222 during the year 2020-21.