GSK claims FDA okay for first oral carbapenem antibiotic
GSK has helped top up the antibiotic armamentarium in the US, after securing the first FDA approval for an oral carbapenem, Utebzi, for adults with complicated urinary tract infections (cUTIs).
While it doesn't offer a novel mechanism of action, Utebzi (tebipenem pivoxil) – which GSK licenses from Spero Therapeutics – provides an oral alternative to the current intravenously administered carbapenems, which are often used as a last resort for infections resistant to other antibiotics.
That means patients may be able to reduce hospital stays or visits to an infusion centre, and potentially be treated entirely at home, which could reduce the risk of patients with cUTIs being exposed to other infections and potentially cut healthcare costs.
"For patients with […] cUTIs and their caregivers, this approval is a major milestone as today's standard of care places a serious burden on them and hospitals," commented Dr Bilal Chughtai, a senior urologist working at Plainview Hospital and Hofstra University/Northwell Health in the US.
"A new effective oral treatment offering an alternative option to intravenous care has the potential to enable more treatment in the outpatient settings," he added.
GSK acquired rights to Utebzi in a $591 million deal in 2022, just a few months after the FDA rejected Spero's first marketing application for the antibiotic with a request for an additional clinical trial.
That study – called PIVOT-PO – compared Utebzi to a standard therapy of IV imipenem-cilastatin for cUTIs, including pyelonephritis, and showed that the two regimens were equally effective at achieving a clinical cure and eradicating the bacteria causing the infection, with a "generally similar" safety profile.
There are estimated to be around 29 million cUTI cases in the US alone every year, many of which are caused by multidrug-resistant (MDR) pathogens, and can result in organ failure, sepsis, and death.
According to GSK, cUTIs cost US health systems around $6 billion a year to manage, with emergency department visits and hospitalisations a significant contributor.
The company – one of the few big pharma companies to still be actively working on new antimicrobials – said it expects to make Utebzi available to patients in the US with cUTIs by the end of the year.
Last year, GSK also won two FDA approvals for the first-in-class triazaacenaphthylene antibiotic, Blujepa (gepotidacin), firstly for cUTIs and then for uncomplicated gonorrhoea. In 2023, the company licensed rights to a novel triterpenoid antifungal approved for yeast infections, Brexafemme (ibrexafungerp), from Scynexis in a $593 million deal.
While pharma companies have argued for years that it is very difficult to get a return on investment in antimicrobial medicines, GSK has suggested its three new products could collectively generate peak sales of more than £2 billion a year.
