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Pfizer launches new antibiotic Zavicefta in UK and Germany

Biopharmaceutical company Pfizer releases MDR antibiotic

Pfizer

Pfizer's new antibiotic for multidrug resistant (MDR) infections - Zavicefta - has been launched in the UK and Germany, its first EU markets.

The European Medicines Agency (EMA) cleared Zavicefta (ceftazidime and avibactam) for the treatment of complicated Gram-negative bacterial infections requiring hospitalisation last year. The drug was originally developed by AstraZeneca (AZ) but sold to Pfizer last year in a $1.58bn deal.

Zavicefta has also already been approved in the US, where it is sold by Allergan as Avycaz, and Pfizer says it intends to roll out the antibiotic in additional markets outside the US "throughout 2017 and 2018."

Pfizer said the new antibiotic was developed in response to the urgent medical need for new antibiotics for difficult-to-treat Gram-negative bacteria, many of which have become increasingly resistant to currently available antibiotics.

Gram-negative bacteria feature prominently in the World Health Organization's (WHO) recently-published list of 12 serious pathogens, on the grounds that these bacteria "have built-in abilities to find new ways to resist treatment and can pass along genetic material that allows other bacteria to become drug-resistant as well."

One of the key roles for the new product is in the treatment of infections with carbapenem-resistant Enterobacteriaceae (CRE), a family that includes pathogens such as Pseudomonas, Klebsiella and Serratia species as well as Escherichia coli.

Carbapenems such as meropenem, ertapenem, imipenem and doripenem are normally reserved for serious infections caused by drug-resistant Gram-negative bacteria, but rates of resistance to these drugs are on the rise and pose a serious threat to public health.

Specifically, Zavicefta is approved in the EU for complicated intra-abdominal infection (cIAI), complicated urinary tract infection (cUTI) and hospital-acquired pneumonia (HAP), but can also be used in the treatment of other serious Gram-negative infections in adults with limited treatment options.

"MDR infections are an increasing global threat," said Matteo Bassetti, chief of the infectious diseases Clinic at University of Udine in Italy.

"The availability of Zavicefta is a major step forward for physicians faced with the challenge of treating patients with known or suspected MDR infections," he added.

The pressing need for new antimicrobial candidates has become a hot topic, with the UK's 2015 Review on Antimicrobial Resistance (AMR) predicting that by 2050 the global cost of MDR will be up to $100trn and account for 10 million extra deaths a year.

Article by
Phil Taylor

15th March 2017

From: Regulatory

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