US EditionSecond Oral Antibiotic for Gonorrhea Gets FDA Green Light
The FDA approved zoliflodacin as the first oral pill and expanded gepotidacin’s use to address rising antibiotic resistance amid nearly 600,000 U.S. gonorrhea cases last year.
- The FDA approved zoliflodacin and gepotidacin in mid-December, marking the first major gonorrhea treatments since ceftriaxone in the mid-1980s.
- Rising antibiotic resistance and a large case burden—more than 80 million global cases and nearly 600,000 U.S. cases last year—prompted development of new gonorrhea treatments.
- On Friday, regulators cleared zoliflodacin after a large trial showed the one‑dose oral pill was safe and effective, with results published Dec. 11 in The Lancet, while gepotidacin, previously approved for urinary tract infections in women, was also approved.
- Both new drugs are approved only for genital and urinary tract infections to preserve effectiveness, with Innoviva Specialty Therapeutics marketing in higher-income countries and GARDP distributing lower-cost versions elsewhere.
- Clinicians, including Dr. Aniruddha Hazra, said the single-pill option could expand treatment uptake as many patients prefer pills over injections, helping prevent infertility and newborn blindness.
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18 Articles
MedPage Today
Anti-Aging, Acupuncture and Health NewsSecond Oral Antibiotic for Gonorrhea Gets FDA Green Light
(MedPage Today) -- The FDA on Friday announced approval of zoliflodacin (Nuzolvence) as an oral treatment for gonorrhea, a day after approving oral gepotidacin (Blujepa) for the same indication. Zoliflodacin is the first of a new class of antibiotics...
The Philadelphia Tribune
WWAY TVFDA approves first new antibiotics to treat gonorrhea in decades, with hope to combat drug resistance
For the first time in decades, the US Food and Drug Administration has signed off on new antibiotics to fight gonorrhea. The approvals come at a critical moment: The sexually transmitted infection is growing harder to treat, and cases continue…
Watauga Democrat
FDA Approves Two New Antibiotics to Treat Drug-Resistant Gonorrhea
Key Takeaways
In November of this year, the World Health Organization (WHO) launched a report warning that gonorrhea is becoming increasingly resistant to antibiotics. And this month, new antibiotics for the treatment of the disease were approved by the Food and Drug Administration (FDA) in the United States: zoliflodacin and gepotidacin. When the mind warned of the danger: rot the bears, procrastinate and other forms of self-sabotage What is the vasovagal sy…
After three decades without a new antibiotic to treat gonorrhea – a sexually transmitted infection – the FDA has approved two oral treatments, first in their class, for this sexually transmitted infection (STIs), which affects more than 80 million people around the world each year. It is Nuzolvence (zoliflodacin) from Innoviva and GSK Blujepa that arrive with just 24 hours of difference in a context in which gonorrhea is increasingly resistant t…
In A Breakthough Against Drug Resistance, FDA Approves New Gonorrhoea Treatment
A new treatment has been approved against gonorrhea, a sexually transmitted infection (STI) that is increasingly developing resistance to all current antibiotics. The US Food and Drug Administration (FDA) approved the use of zoliflodacin to treat uncomplicated gonorrhoea on Friday, following the publication in The Lancet of the results of a phase 3 trial of […]
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