New antibiotic approved for drug-resistant infections

A new antibiotic, developed with support from Wellcome, has been approved for patient use in the US.

The US Food and Drug Administration (FDA) has approved the use of plazomicin (brand name ZEMDRI) for the treatment of complicated, drug-resistant urinary tract infections.

Wellcome supported development of the new medicine, including £8.1m funding for pre-clinical research and Phase 2 development.

The rapid rise and spread of untreatable superbugs is a serious and global health threat, currently killing around 700,000 people a year globally.

Tim Jinks, Head of Wellcome’s Drug-Resistant Infections Programme said: "This new antibiotic will be a vital last-resort treatment for patients with complicated and life-threatening urinary tract infections. As with any new antibiotic, ensuring appropriate use is essential.

"Developing new treatments is a key part of the global effort against superbugs – but it is complex, costly and challenging. It has taken more than a decade to get this medicine from promising laboratory research to a safe, approved medicine for patients."

Plazomicin is not a new class of antibiotics, but has been developed to treat infections caused by drug-resistant Enterobacteriaceae – a Gram-negative bacteria identified by the World Health Organisation (WHO) as one of the three superbugs that are most difficult to treat.

No approved antibiotic drug class has been discovered since 1980. Of even greater concern is the fact that no new class of antibiotics has been discovered to treat Gram-negative bacteria since 1962. These bacteria include most of the superbugs that the WHO consider the greatest threat to human health.

Wellcome’s support and funding for plazomicin’s development was provided by our Innovations team, and is part of our wider, ongoing programme to address drug-resistant infections globally.

An initial award of £4.7m was granted in 2008 for early, investigational research. A further £3.4m was awarded in 2010 for Phase 2 clinical trials.

In the past two years, R&D into new antibiotics has increased thanks to public-private investment, including initiatives such as CARB-X and GARDP, both of which Wellcome funds.

We are calling for wider investment and collaboration to ensure delivery of the new treatments needed globally and are working with governments and industry to develop and implement workable, balanced incentives for the broken antibiotics market.

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