The GlaxoSmithKline product gepotidacin that was approved this time will be sold under the brand name Blujepa. The approval gives Glaxo a much-needed victory at a time when risks to the company's pipeline have raised concerns among activist investors. At the same time, there is a growing need for antibiotics with new ways of killing bacteria that cause infections.
GlaxoSmithKline expects Blujepa to generate annual sales of up to 2 billion pounds (about $2.6 billion), in addition to two other anti-infective drugs in development. The approved product is one of five major products the UK-based company expects to launch this year.
In two late-stage trials, Blujepa, a new oral antibiotic, was as effective as or equal to the gold standard drug in treating urinary tract infections.
Tony Wood, chief scientific officer of GlaxoSmithKline, said in a conference call with reporters on Tuesday: "Simple urinary tract infection is the most common infectious disease among women." He pointed out that in the United States, up to 16 million women suffer from it every year, and more than half of women will encounter some form of infection in their lifetime.
Blujepa targets only E. coli bacteria, which means it is less likely to trigger bacterial resistance than antibiotics that target a wide range of bacterial species.
The new antibiotic is also currently being tested as a treatment for gonorrhea. Studies have shown that it is as effective as a combination of drugs used to treat gonorrhea, one of which also requires an intramuscular injection.