U.S. FDA grants approval for two drugs to treat gonorrhoea

The U.S. Food and Drug Administration (FDA) has granted approval for two new oral medicines to treat gonorrhoea, a common sexually transmitted infection, prone to resistance against drugs. Indian pharma major Dr. Reddy’s is taking steps to obtain market authorisation for one of these drugs in Thailand and South Africa, and its unit, Aurigene Pharmaceutical Services, will manufacture the drug. 

The two drugs – Nuzolvence (zoliflodacin) which comprises granules that dissolve in water and Blujepa (gepotidacin) oral tablets – add a critical element to the armamentarium in a world where the tools to treat gonorrhoea are fast shrinking. “These approvals mark a significant milestone for treatment options for patients with uncomplicated urogenital gonorrhea,” said Adam Sherwat, director, Office of Infectious Diseases, FDA’s Center for Drug Evaluation and Research, in a release. FDA approval for Nozolvence was granted to Entasis Therapeutics and approval for Blujepa was granted to GSK.  

While Blujepa was developed by GSK, Nuzolvence was a project initiated by Astra Zeneca, but dropped, and later taken up by Entasis which partnered with the nonprofit Global Antibiotic Research and Development Partnership (GARDP), beginning trials in 2019.  

‘High priority’ pathogen

The World Health Organization (WHO) maintains a list of critical pathogens, with a focus on antibiotic-resistant bacteria; the 2024 list includes the gonorrhoea-causing bacteria Neisseria gonorrhoeae, classified as “high priority”. The reason is that it is prone to evasive drug action and is growing increasingly resistant to the one drug/drug combination that is being used globally as treatment.  

Gonorrhoea is spread through sexual contact and usually affects the throat, rectum, genitals, and eyes, and can lead to painful urination, bleeding and discharge in the genital area. It often goes untreated because a number of people who have contracted the infection, particularly women, show no symptoms, but it can potentially cause infertility or complications if not treated.  

Cases on the rise

In 2020, the WHO estimated 82.4 million new infections among adults aged 15 to 49 years. One reason this might be increasing, explains Pierre Damar, R&D Drug and treatment project leader at GARDP, is because of the revolution in the field of treatment for HIV/AIDS. “The younger generations have stopped using condoms because the fear of HIV is not there anymore. They are using Pre -Exposure Prophylaxis  (PrEP) – which is medicine people at risk for HIV take to prevent getting HIV from sex or injecting drug use. However, PrEP cannot protect you against contracting STIs. It has already been shown that the cases of gonorrhoea are increasing. There were almost no new cases during the pandemic lockdown, but [it] seems to have exploded soon after.” 

Dr. Daram says zoliflodacin remains the only drug to treat gonorrhoea (Blujepa is also used to treat urinary tract infections) as a  key part of GARDP’s STI strategy. “Limiting its clinical use in this way should support good stewardship of the drug and help to delay the emergence of resistance, thereby prolonging the effectiveness of this  new drug.”  

Government partnerships

The drug, which is given orally in a single dose, and therefore convenient for the patient, will first be available in Thailand and in South Africa, two countries where clinical trials were also conducted. GARDP will also look at partnerships, including with governments, that will enable easy access to the drug in these countries, Dr. Daram adds.