Britain approves GSK’s antibiotic for female urinary tract infections

Britain’s medicines regulator has approved GSK’s new antibiotic pill Blujepa to treat uncomplicated urinary tract infections in women, boosting the drugmaker’s plans to broaden its revenue streams amid competitive pressures.

The active ingredient in Blujepa, chemically known as gepotidacin, targets and blocks two enzymes that bacteria need to replicate and multiply, making it work against many drug-resistant infections such as E. coli, the Medicines and Healthcare products Regulatory Agency (MHRA) said on Aug 28.

It added the medicine was approved for females aged 12 and older, and weighing at least 40kg, and was the first of its kind in nearly 30 years. The recommended dose is two tablets twice daily for five days, approximately every 12 hours.

GSK welcomed the MHRA’s decision and said it would work with the British health authorities and Britain’s National Institute of Health and Care Excellence (Nice) to make Blujepa available for eligible patients.

Britain’s Nice determines the cost-effectiveness of treatments paid for by public funds.

The British approval for Blujepa follows that of the US Food and Drug Administration (FDA) in March.

The FDA in August also accepted GSK’s application for a priority review of gepotidacin in treating sexually transmitted urogenital gonorrhoea. A decision on that is expected in December.

GSK is focusing on expanding its product pipeline and banking on new approvals, including in its infectious diseases portfolio, to make up for lost revenues from its best-selling medicines and vaccines and looming human immunodeficiency virus (HIV) treatment patent losses.

While GSK has not given a sales target for Blujepa, it has said it expects the medicine, along with two others in development, to generate peak yearly sales of more than £2 billion (S$3.5 billion).

It is hoping to reach overall annual sales of over £40 billion by 2031. REUTERS