All posts tagged: supergonorrhoea

New drug for super-gonorrhoea points to better antibiotic development

New drug for super-gonorrhoea points to better antibiotic development

GARDP funded and led the pivotal clinical trial, the largest gonorrhoea trial ever undertaken. Enrolling 930 patients across 16 sites in Belgium, the Netherlands, South Africa, Thailand and the US, the trial generated evidence reflecting real-world use. This model also allows access planning to begin long before regulatory approval. GARDP worked with India-based Dr Reddy’s Laboratories on registration and commercialisation, helping lay the groundwork for rapid introduction in high burden countries. Working closely with regulators is equally important. The Thai FDA’s decision to grant priority review helped make Thailand only the second country in the world to approve the drug and is a great example on how national regulators can take decisions that will allow their populations to get early access. With zoliflodacin now approved in the US and Thailand under the brand name Nuzolvence, and preparations underway in other countries, GARDP is committed to ensuring the antibiotic reaches the people who need it most as quickly as possible. Zoliflodacin shows that it is possible to break the cycle that has left much of the …