By Kamal Choudhury
Dec 12 (Reuters) – The U.S. health regulator on Friday approved Innoviva’s oral antibiotic to treat gonorrhea, a common sexually transmitted infection, offering patients an alternative to an injectable drug that was the only recommended treatment until now.
The Food and Drug Administration’s approval of the drug, branded as Nuzolvence, addresses a growing public health crisis as gonorrhea has developed resistance to nearly all available antibiotics.
For now, Roche’s decades-old injection ceftriaxone remains the sole treatment recommended by the CDC.
Gonorrhea causes about 82 million new infections globally each year and can lead to serious complications, including infertility, if left untreated, according to the WHO.
Nuzolvence, developed by Innoviva Specialty Therapeutics, a unit of Innoviva, in partnership with Global Antibiotic Research & Development Partnership (GARDP), is an oral antibiotic for the treatment of uncomplicated gonorrhea in patients aged 12 years and older who weigh at least 77 pounds.
The company said it plans to make Nuzolvence available in the second half of 2026, either in collaboration with a commercialization partner or independently, and will share pricing details at a later date.
“The price will vary from one country to another and has not yet been determined,” a spokesperson for GARDP told Reuters, adding that “it will likely be an order of magnitude cheaper than the expected price in the U.S.”
It works by blocking a bacterial enzyme essential for reproduction, using a mechanism different from current antibiotics. The drug is designed to target strains that are multidrug-resistant, including ceftriaxone.
In a late-stage trial of 930 patients, Nuzolvence met its main goal of proving non-inferior to the standard shot for clearing infection at genital sites and showing similar results at throat and rectal sites, when combined with standard regimen of ceftriaxone plus Pfizer’s azithromycin.
Earlier this week, the health regulator also expanded the use of GSK’s Blujepa as an oral treatment for gonorrhea.
(Reporting by Kamal Choudhury, Padmanabhan Ananthan and additional reporting by Mariam Sunny in Bengaluru; Editing by Krishna Chandra Eluri and Shailesh Kuber)
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