Orchid Pharma's Exblifeb granted EMA approval
Drug Approval

Orchid Pharma's Exblifeb granted EMA approval

Exblifeb demonstrates remarkable efficacy in treating complicated Urinary Tract Infections (cUTI), pneumonia

  • By IPP Bureau | February 01, 2024

Orchid Pharma has achieved a significant breakthrough with its antibiotic invention, 'Exblifeb,' which incorporates Enmetazobactam, the first completely invented-in-India Beta Lactamase Inhibitor. This pioneering drug recently received the European Medicines Agency's (EMA) recommendation for marketing authorization, marking the first instance of an Indian-invented drug reaching this stage of clinical development.

Designed to address the global challenge of Anti-Microbial Resistance (AMR), 'Exblifeb' demonstrates remarkable efficacy in treating complicated Urinary Tract Infections (cUTI), pneumonia, and bacteremia caused by Extended Spectrum Beta-lactamase producing pathogens. During clinical trials, 'Exblifeb' exhibited superior performance compared to the current go-to drug, Piperacillin + Tazobactam. It is positioned as a potent, cost-effective, and Carbapenem-sparing therapy, offering a viable solution in the fight against rising AMR.

This milestone not only positions 'Exblifeb' as a front-runner in combating AMR but also underscores the urgent need for effective solutions. According to the Global Burden of Disease Study, infections caused by antimicrobial-resistant bacteria led to the direct death of 1.27 million people in 2019. 'Exblifeb,' with its unique Indian origin and superior clinical performance, has the potential to become a standard of care worldwide in addressing this global health crisis.

Manish Dhanuka, Managing Director, Orchid Pharma, celebrating this development said, "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."

Enmetazobactam was invented in India by Orchid and then out-licensed to Allecra Therapeutics for further development.

Upcoming E-conference

Other Related stories