First new antibiotic for UTIs in 20 years approved to help millions of women who don't respond to other drugs

For the first time in two decades, a new pill for urinary tract infections has been approved in hopes of combating bugs that are resistant to antibiotics.

The FDA has approved the drug pivmecillinam - sold under the brand name Pivya - for 'uncomplicated' UTIs, meaning the infection is contained within the bladder and has not spread to the kidneys.

It has been used as a first-line treatment in Europe for over 40 years but will become available on prescription to millions of US women over the age of 18 next year.

Utility Therapeutics, the company developing the drug, is also seeking approval for a intravenous version given in the hospital for more serious infections.

The FDA has approved the drug pivmecillinam - sold as Pivya in the US - for 'uncomplicated' UTIs, meaning the infection is contained within the bladder and has not spread to the kidneys

'Uncomplicated UTIs are a very common condition impacting women and one of the most frequent reasons for antibiotic use,' said Dr Peter Kim, director of the Division of Anti-Infectives in the FDA's Center for Drug Evaluation and Research.

'The FDA is committed to fostering new antibiotic availability when they prove to be safe and effective.' 

It is the first time in 20 years that the FDA has approved a new antibiotic for UTIs, which affects 30 million Americans every year.

EXCLUSIVEEXCLUSIVE: Doctors warn of a sepsis crisis that's killing one American every 90 seconds

The toddler who fell of his bike and scraped his knee. The woman with a common bowel disease injury. And the man with Strep throat.

Antibiotic resistance is a growing issue, when pathogens adapt in a way that allows them to resist potent medications designed to kill them.

The problem is associated with almost five million deaths, according to the World Health Organization.

The majority of UTIs happen when bacteria such as E.coli travels from the rectum, genital area or vagina into the urethra and the bladder.

As the bacteria multiples, patients can suffer abdominal cramping, burning sensations and blood in their pee.

While men can contract UTIs, the problem overwhelmingly affects women more often. Over half of women in the US will get a UTI at some point in their life, compared to just 14 percent of men.

This is because women have shorter urethras than men, which means it is easier for bacteria to get to the urinary tract.

About a quarter of women suffer from recurrent UTIs, which is defined as at least two infections in six months, or three in a year. 

Most UTIs are now resistant to at least one antibiotic. Ampicillin, which once upon a time was a common treatment, is now rarely used.

Studies have shown that more than 92 percent of bacteria that cause a UTI are resistant to at least one common antibiotic, and close to 80 percent are resistant to at least two.

If infections have reached the kidneys or go into the bloodstream, this makes them harder to treat. 

Pivmecillinam has been prescribed more than 30 million times in Europe, with most use occurring in Nordic countries, and reports of complications have been rare.

The most frequent side effects of pivmecillinam in clinical trials were nausea and diarrhea, the FDA said. 

Dr Shruti Gohil, a professor of infectious diseases at the University of California, Irvine School of Medicine, told The New York Times pivmecillinam represented an 'exciting new possibility for treatment of lower urinary tract infections.'

'But I would also say that it is going to be important that we use the drug responsibly in this country so that we don't breed resistance against it.'