INDIA – Alkem Laboratories Ltd. has expanded its product portfolio with the launch of its novel antibiotic that is effective against multidrug-resistant (MDR) bacteria under the brand name “Zidavi” in India.
Zidavi is approved by the U.S. Food and Drug Administration (USFDA), European Medicines Agency (EMA), and Central Drugs Standard Control Organisation (CDSCO) for the treatment of hospital-acquired pneumonia (HAP) and complicated intra-abdominal infections (IAIs).
It is a novel combination of ceftazidime and avibactam that will help to combat multidrug-resistant and persistent infectious diseases in India.
In a press release, Alkem said that Zidavi, which is a novel combination of ceftazidime and avibactam, will be available in the form of a sterile powdered concentrate for reconstitution in an amount strength of 2.5g.
“Each single-dose vial contains ceftazidime pentahydrate equivalent to 2g ceftazidime and avibactam sodium equivalent to 0.5g avibactam,” said India’s speciality pharmaceutical company.
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.
Alkem confirmed that the Infectious Disease Society of America (IDSA) and the Indian Council of Medical Research (ICMR) have recommended the use of its new resistance-busting antibiotic combination, Zidavi.
Zidavi is 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.
Studies highlight that new antibiotics are no longer being discovered, resistance mechanisms are occurring in almost all clinical isolates of bacteria, and recurrent infections caused by persistent bacteria are hampering the successful treatment of infections.
With the rise in infections caused by carbapenem-resistant Gram-negative organisms in India, there is a need for more effective antibiotic treatment. MDR infections pose a real threat to immunocompromised patients, causing severe infections with poor outcomes.
The fixed-dose combination of ceftazidime and avibactam
“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,” said Alkem.
The launch of Alkem’s antibiotic for MDR infections is in line with the company’s endeavour to ensure affordability, accessibility, and availability while saving the lives of critically ill patients.
In addition, Zidavi presents a promising therapeutic option for the treatment of infections complicated by MDR Gram-negative pathogens & all the evidence favours its use in the Indian setting.
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