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Shionogi scores FDA approval for new cUTI antibiotic

Pivotal new treatment for adults with complicated urinary tract infection


Japanese pharma Shionogi has won FDA approval for its antimicrobial drug Fetroja, in the treatment of adult patients with complicated urinary tract infections (cUTI) who have limited or no alternative treatment options. 

The approval comes at a time of increasing antibiotic resistance around the world. According to a recent report from the US Centers for Disease Control and Prevention (CDC), drug-resistant infections affect around three million people every year in the US and kill approximately 35,000.

The development of new antibiotics is pivotal to combating this rising trend, and to address areas of high unmet need.

The approval of Fetroja was based on the results of the APEKS-cUTI study. The data from this phase 3 trial demonstrated that the response rates for the composite endpoint of microbiological eradication and clinical response at the test of cure were significantly higher in the Fetroja treatment arm compared to the older antibiotic (imipenem/cilastatin) arm.

“Fetroja will fill a very important unmet medical need because of its unique method of penetrating the cell wall of Gram-negative bacteria and its ability to overcome many of the resistance mechanisms that bacteria employ against antibiotics,” said Isao Teshirogi, president and CEO of Shionogi.

Also looking to bring a new antibiotic to market is GlaxoSmithKline, which recently initiated two phase 3 trials of its new-class candidate. It is initially being developed to treat uncomplicated urinary tract infection (ITI) and urogential gonorrhoea.

The EAGLE-1 trial will enrol 6000 patients with gonorrhoea and the EAGLE-2 trial has a target population of 1,200 people with UTIs which are confined to the lower urinary tract.

The development of new drugs to treat antibiotic resistant germs is well overdue, as pharma companies have halted research in this area as there is no significant payback for the cost of R&D. This is due to the fact that the newest, most effective drugs are usually kept in reserve and only used when infections do not respond to older agents.

However, as these cases are on the rise globally, governments across the world are incentivising the development of new antibiotics to encourage pharma companies to re-start their efforts.

One of these proposed schemes comes from the UK Government, which plans to trial a subscription-style payment model with pharma companies, in which an upfront payment will be made for access to drugs that can treat antibiotic resistant infections.

Article by
Lucy Parsons

15th November 2019

From: Regulatory



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