Orchid Pharma’s New Antibiotic ‘Exblifeb’ Receives European Medicines Agency Approval
Chennai-based pharmaceutical company Orchid Pharma announced on Tuesday that its antibiotic ‘Exblifeb’ has been granted approval by the European Medicines Agency (EMA) for marketing and distribution. This breakthrough drug incorporates Enmetazobactam, touted as the first completely invented-in-India Beta Lactamase inhibitor, and aims to combat the growing threat of antimicrobial resistance (AMR) worldwide.
With an emphasis on addressing the challenges posed by AMR, ‘Exblifeb’ has displayed significant effectiveness in treating complicated urinary tract infections (UTI), pneumonia, and bacteremia caused by extended spectrum beta-lactamase producing pathogens, according to the company’s regulatory filing.
During clinical trials, ‘Exblifeb’ demonstrated superior performance when compared to the current standard drug, Piperacillin + Tazobactam. Given its potential to save numerous lives globally, the EMA approval serves as a testament to Indian innovation and a source of great pride, according to Orchid Pharma’s Managing Director, Manish Dhanuka.
Enmetazobactam, the key component of ‘Exblifeb,’ was initially developed by Orchid Pharma in India and subsequently licensed to Allecra Therapeutics for further refinement and development.
This approval not only showcases India’s role as the pharmacy of the world but also highlights the nation’s significant achievement in spearheading the creation of a novel drug for the first time.
With AMR becoming a pressing concern across the globe, the approval of ‘Exblifeb’ holds immense promise for combatting life-threatening infections. The inclusion of Enmetazobactam, an entirely Indian innovation, marks a significant milestone for the pharmaceutical industry and opens up new possibilities for addressing the ever-evolving challenges of healthcare.
By obtaining EMA approval, ‘Exblifeb’ can now be introduced to a wider market, providing physicians with a vital tool to tackle infections caused by drug-resistant pathogens. The positive clinical trial results and the drug’s potential to outperform existing treatments offer hope for patients who encounter difficult-to-treat urinary tract infections, pneumonia, and bacteremia.
Orchid Pharma’s accomplishment not only showcases the company’s commitment to scientific advancement but also demonstrates India’s increasing influence in the global pharmaceutical landscape. With the urgent need for innovative antibiotics, the approval of ‘Exblifeb’ ushers in a new era in the fight against antimicrobial resistance.
As the world grapples with the evolving challenges of public health crises, the development and approval of novel antibiotics such as ‘Exblifeb’ are crucial to safeguarding human lives. Orchid Pharma’s breakthrough serves as a reminder of the importance of ongoing research, development, and collaboration in the quest for effective solutions against drug-resistant infections.
The approval of ‘Exblifeb’ by the EMA signifies another significant step forward in the battle against antimicrobial resistance. By highlighting Indian innovation and scientific achievements, this milestone strengthens the country’s standing as a key player in the global healthcare arena.
With millions of lives potentially at stake, the availability and accessibility of effective antibiotics are vital in overcoming the devastating impact of drug-resistant infections. Orchid Pharma’s ‘Exblifeb’ sets the stage for a future in which medical professionals can tackle complex infections with confidence, offering a newfound ray of hope to patients in need around the world.
