Actavis and AZ see FDA approval for ‘superbug’ drug
pharmafile | February 27, 2015 | News story | Research and Development, Sales and Marketing | Actavis, AstraZeneca, Avycaz, FDA, US, ceftazidime/avibactam
Actavis and AstraZeneca’s combo ‘superbug’ drug Avycaz has been shown the green light to treat patients with complicated intra-abdominal infections (cIAI).
Avycaz (ceftazidime/avibactam) was given priority review making it the fifth approved antibacterial drug product designated as a Qualified Infectious Disease Product (QIDP) – which awards it an additional five years of marketing exclusivity.
It can be used in combination with generic antibiotic metronidazole – which is on the World Health Organization’s list of essential medicines – to treat adults with cIAI, plus as a standalone medication for urinary tract infections (cUTI).
Edward Cox, who is the director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, warns: “It is important that the use of Avycaz be reserved to situations when there are limited or no alternative antibacterial drugs for treating a patient’s infection.”
The antibacterial treatment was studied in two Phase II trials, one each in cIAI and cUTI. The most common side effects reported included vomiting, nausea, constipation and anxiety.
Concerns surrounding ‘superbugs’ have been around for some time now, stretching back to 2008 when it was announced that millions of pounds in extra funding would be given to hospitals in England to help control the spread of bacteria.
More recently it was reported that around 179 patients at the Ronald Reagan UCLA Medical Center may have been exposed to a potentially deadly superbug.
In a statement the hospital said the exposure to carbapenem-resistant Enterobacteriaceae (CRE) – a bacteria that can kill up to half of patients who get bloodstream infections – happened “during complex endoscopic procedures between October 2014 and January 2015”.
CRE is challenging to treat because the germs have high levels of resistance to antibiotics, according to the Centers for Disease Control and Prevention.
To tackle the growing threat of antimicrobial resistance (AMR) NICE is encouraging medical professionals in England to prescribe and promote the sensible use of antibiotics to preserve their future effectiveness.
The new strategy by the UK body comes after a government-funded report predicted that antibiotic-resistant bacteria could kill an extra 10 million people a year by 2050.
Gabelli Co analyst Kevin Kedra, concludes: “The drug has shown good activity against a variety of tough-to-treat infections and gives doctors another option, especially if their first choice runs into issues of resistance.”
Actavis and AstraZeneca’s offering will be available from the second quarter of this year.
Tom Robinson
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