(Reuters) -Britain's Medicines and Healthcare products Regulatory Agency (MHRA) on Thursday said it approved gepotidacin, also known as Blujepa, a new kind of oral antibiotic pill to treat
UK Grants Approval for GSK's New Antibiotic for Women's UTIs
GSK's Blujepa: A New Hope for UTIs
(Reuters) -Britain's medicines regulator has approved GSK's new antibiotic pill Blujepa to treat uncomplicated urinary tract infections in females, boosting the drugmaker's plans to broaden its revenue streams amid competitive pressures.
Mechanism of Action
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 Thursday.
Approval Process and Future Plans
It added the medicine was approved for females aged 12 and older and weighing at least 40kg (88lbs), 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.
Market Expectations
GSK welcomed the MHRA's decision and said it would work with UK health authorities and the 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 UK approval for Blujepa follows that of the U.S. Food and Drug Administration in March.
The FDA this month 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 HIV treatment patent losses.
While GSK has not given a sales target for Blujepa, it has said it expects the medicine, along with two other medicines in development, to generate peak yearly sales of more than 2 billion pounds ($2.7 billion).
It is hoping to reach overall annual sales of over 40 billion pounds by 2031.
($1 = 0.7402 pounds)
(Reporting by Angela Christy and DhanushVignesh Babu in Bengaluru. Editing by Leslie Adler and Mark Potter)
