Alkem becomes first Indian company to launch novel antibiotic for MDR infections

Alkem has launched 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, a company statement said.

Zidavi, 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 E nterobacteriaceae (CRE) for pyelonephritis or Complicated Urinary Tract Infections (cUTI) and in other CRE infections caused by KPC and OXA-48 producers, the statement added.

Further, according to the statement, 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 United States 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).

It also mentioned that Zidavi 2.5 g (ceftazidime and avibactam) for infusion is available as a sterile powdered concentrate for reconstitution. Each single-dose vial contains ceftazidime pentahydrate equivalent to 2 g ceftazidime and avibactam sodium equivalent to 0.5 g avibactam. It is available at a price of Rs 2,700/vial. Zidavi’s strength lies in its Active Pharma Ingredients (APIs), which is manufactured in the company’s state-of-the-art manufacturing plant in Sikkim.

Combination therapy with ceftazidime-avibactam presents a promising therapeutic option for the treatment of infections complicated by MDR gram-negative pathogens and all the evidence favours the use of Zidavi (ceftazidime-avibactam) in the Indian setting, the statement concluded.