A potential blockbuster antibiotic from GSK Plc to treat urinary tract infections outperformed the current gold standard drug for the condition in advanced trials, a development that could be a boon for the UK drug maker.
(Bloomberg) — A potential blockbuster antibiotic from GSK Plc to treat urinary tract infections outperformed the current gold standard drug for the condition in advanced trials, a development that could be a boon for the UK drug maker.
Gepotidacin demonstrated efficacy of 50.6% and 58.5% in two advanced trials for the treatment of uncomplicated infections, higher than the 43.6% and 47% shown by nitrofurantoin, the most commonly used antibiotic now, according to results published by GSK on Saturday and presented at the European Congress of Clinical Microbiology and Infectious Diseases in Denmark.
GSK expects the medicine to be a potential blockbuster – generating revenues of at least $1 billion annually for its portfolio. The UK drug maker is under pressure to improve its performance after splitting from its consumer business last year in an effort to refocus on building its pharma and vaccines business.
The company is planning to apply for US regulatory authorization in the second quarter with approval expected in early 2024. The drug is the first breakthrough, in terms of higher efficacy compared to the market leader, in more than two decades.
“We’re trying to bring through a medicine for an area that’s been overlooked for a long period of time,” Robert Bowers, GSK’s antibiotics commercial lead, said in an interview. Antibiotic resistance has been increasing in the community as well as hospitals, underscoring the high need for this drug, he said.
Over half of women globally are affected by such infections at least once in their lifetime and more than a quarter will experience several times. With growing resistance to antibiotics treatment options are likely to be more limited.
GSK has been investing more broadly in drugs that affect women’s health particularly, with the purchase of a new anti-fungal treatment from a US biotech last month to treat vaginal yeast infections, for which it forecast sales of more than $500 million, and tebipenem, a drug the company is currently trialling against UTIs at risk of complications.
Unusually for big pharma, gepotidacin is a home-grown GSK medicine discovered by its scientists in 2007. The drug is also in trials to treat gonorrhea.
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