Alkem becomes First Indian company to launch novel antibiotic for Multiple drug resistance (MDR) infections

Alkem (Intenza, critical care division) has announced the launch of its novel anti-infective in India under the brand name Zidavi. This is in line with company’s endeavour to ensure affordability, accessibility, and availability while saving the lives of critically ill patients.
Zidavi, which is a novel combination of ceftazidime and avibactam, is recommended by the Infectious Disease Society of America (IDSA) and the Indian Council of Medical Research (ICMR) as a preferred treatment against OXA-48-like and Klebsiella pneumoniae carbapenemase (KPC)-producing carbapenem-resistant Enterobacteriaceae (CRE) for pyelonephritis or Complicated Urinary Tract Infections (cUTI) and in other CRE infections caused by KPC and OXA-48 producers. 
With the rise in infections caused by carbapenem-resistant Gram-negative organisms in India, there is a need for more effective antibiotic treatment. The available evidence suggests that Zidavi (ceftazidime-avibactam) is a potential therapeutic option for the treatment of infections complicated by multi-drug resistant (MDR) organisms. This combination has also been approved by the U.S. Food and Drug Administration (USFDA), European Medicines Agency (EMA), and Central Drugs Standard Control Organisation (CDSCO) as an effective alternative to meropenem and colistin in hospital-acquired pneumonia (HAP) and complicated intra-abdominal infections (IAIs).
Zidavi 2.5g (ceftazidime and avibactam) for infusion is available as a sterile powdered concentrate for reconstitution. Each single-dose vial contains ceftazidime pentahydrate equivalent to 2g ceftazidime and avibactam sodium equivalent to 0.5g avibactam. It is available at an affordable price of Rs. 2,700/vial. Zidavi’s strength lies in its indigenously developed (Active Pharmaceutical Ingredients) API, which is manufactured in the company’s state-of-the-art manufacturing plant in Sikkim.
“With the launch of Zidavi, our aim is to ensure that Alkem continues to remain at the forefront while partnering with clinicians for saving lives,” said company spokesperson. 
Combination therapy with ceftazidime-avibactam presents a promising therapeutic option for the treatment of infections complicated by MDR Gram-negative pathogens & all the evidence favors the use of Zidavi (ceftazidime-avibactam) in the Indian setting.
Alkem is a leading Indian global pharmaceutical company that manufactures and markets biosimilars and pharmaceutical formulations in India and across the globe.

editor