DCGI nod to Orchid Pharma Antibiotic Drug Combination of Cefepime, Enmetazobactam (NCE)

DCGI has also granted permission to manufacture and market Finished Dosage Form (FDF) of Cefepime and Enmetazobactam as a dry powder injectable. This formulation is indicated for the treatment of complicated Urinary Tract Infections (cUTI) including acute Pyelonephritis, Hospital-Acquired Pneumonia (HAP) including Ventilator-associated pneumonia (VAP), and Bacteremia when it is associated or suspected to be associated with either complicated urinary tract infections or hospital-acquired pneumonia.

Anti-Microbial resistance (AMR) is declared as the silent pandemic by UN and WHO and it has contributed to almost 5mn deaths in 2019. In addition to death and disability, AMR has significant economic costs. The World Bank estimates that AMR could result in US$ 1 trillion additional healthcare costs by 2050, and US$ 1 trillion to US$ 3.4 trillion gross domestic product (GDP) losses per year by 2030. This new Combination Drug, provides a powerful treatment option against a range of severe infections caused by resistant bacteria, addressing a critical need in combating antimicrobial resistance.

Speaking on the approval, Manish Dhanuka, Managing Director, Orchid Pharma, said, “Enmetazobactam’s approval in India is personally fulfilling as being an Indian company, we wanted to expand access to advanced and affordable treatment options for patients in India. Orchid Pharma is committed to innovation and is poised to provide an effective solution for patients suffering from severe infections, particularly in the face of rising antimicrobial resistance. We continue our dedicated efforts towards research and development to address unmet medical needs.”

"The company looks forward to the successful launch and distribution of Enmetazobactam and its combination with Cefepime for enhancing the treatment landscape for severe infections in India," Orchid stated in a release.