Press "Enter" to skip to content

Orchid Pharma’s ‘Exblifep’ granted European Medicines Agency approval

Orchid Pharma, based in Chennai, India, has achieved a significant breakthrough with its anti-biotic 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.

Mr 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.

Be First to Comment

Leave a Reply

Your email address will not be published. Required fields are marked *