Exblifeb’ demonstrates remarkable efficacy in treating complicated urinary tract infections (UTI), pneumonia, and bacteremia caused by extended spectrum beta-lactamase producing pathogens, Orchid Pharma said in a regulatory filing.
During clinical trials, ‘Exblifeb’ exhibited superior performance compared to the current go-to drug, (Piperacillin + Tazobactam), it added.
“With the potential to save thousands of lives globally, this approval by EMA is a testament to Indian ingenuity. It is also a matter of great pride that as the pharmacy of the world, India has now developed a new drug for the first time,” Orchid Pharma Managing Director Manish Dhanuka.
Enmetazobactam was invented in India by Orchid and then out-licensed to Allecra Therapeutics for further development.