Drugmaker Innoviva Specialty Therapeutics announced today that the US Food and Drug Administration (FDA) has accepted its new drug application (NDA) for zoliflodacin, an investigational oral antibiotic for uncomplicated gonorrhea.
If the FDA approves the drug, it would be the first new antibiotic for gonorrhea in decades and a much-needed weapon against the second most common sexually transmitted infection in the world. Gonorrhea causes an estimated 82 million new infections annually, and is becoming increasingly resistant to ceftriaxone, the last remaining empiric treatment option for gonorrhea infections.
Rising resistance to ceftriaxone, along with resistance to many other antibiotics that have been used to treat gonorrhea over the decades, has raised concerns about the spread of highly drug-resistant and untreatable gonorrhea, which can cause pelvic inflammatory disease, ectopic pregnancies, and infertility.
"Today’s acceptance of the zoliflodacin NDA marks significant progress toward delivering health care providers with a potential new oral treatment option for uncomplicated gonorrhea, including infections caused by drug-resistant strains," David Altarac, MD, Innoviva's chief medical officer, said in a company press release. "We look forward to working closely with the FDA during its review and, if approved, we are committed to expediting the availability of zoliflodacin to patients in the U.S."
Unique mechanism of action
Zoliflodacin is a first-in-class antibiotic with a different mechanism of action against Neisseria gonorrhoeae than currently available therapies. Supporting data in the NDA include a phase 3 clinical trial in which a single dose of zoliflodacin demonstrated noninferiority in achieving microbiologic cure at the urogenital site compared with the standard regimen of ceftriaxone plus azithromycin, with no serious adverse events or deaths reported. In vitro studies have also shown activity against multidrug-resistant gonorrhea strains and no cross-resistance to other antibiotics.
Innoviva has been developing zoliflodacin in collaboration with the Global Antibiotic Research & Development Partnership (GARDP), which sponsored the phase 3 trial and in return acquired the rights to register and commercialize the drug in low- and middle-income countries. Innoviva retains the commercial rights in major markets in North America, Europe, Asia-Pacific, and Latin America.
"This important milestone demonstrates the crucial role that public-private partnerships can play in tackling the escalating global antimicrobial resistance crisis," said GARDP Executive Director Manica Balasegaram, MRCP, MSc. "If zoliflodacin is approved, this collaboration paves the way for millions of people across the world to get access to a potentially powerful new drug to treat multidrug-resistant gonorrhea."
Another novel oral antibiotic, gepotidacin, has also shown promising results against gonorrhea. The results of a phase 3 trial published earlier this year showed gepotidacin, which is already approved for urinary tract infections, was noninferior to the standard regimen, with a 93% treatment success rate and no new safety concerns.
If zoliflodacin is approved, this collaboration paves the way for millions of people across the world to get access to a potentially powerful new drug to treat multidrug-resistant gonorrhea.
