Orchid Pharma on Tuesday said it has received approval from the European Medicines Agency for marketing its antibiotic ‘Exblifeb’. The Chennai-based firm said Exblifeb incorporates Enmetazobactam, “the first completely invented-in-India Beta Lactamase inhibitor” and it is designed to address the global challenge of antimicrobial resistance (AMR).
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.
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.