Starpharma Holdings Ltd. said the U.S. Food and Drug Administration has asked for confirmatory clinical data in order to approve its antibacterial gel VivaGel BV.
The Australian pharmaceutical company had submitted a new drug application, or NDA, with the U.S. regulator in April seeking approval of VivaGel BV to treat and prevent bacterial vaginosis, or BV — a common bacterial infection in women.
Starpharma CEO Jackie Fairley said, "clearly we are surprised and extremely disappointed with the FDA's requirement for confirmatory data in order to approve the NDA for VivaGel BV considering the comprehensive nature of the data provided." He, however, added that the U.S. regulator did not find any issues in relation to the safety, manufacturing or quality of the product.
The company also noted that the FDA acknowledged the demonstrated efficacy benefits of the antibacterial gel in its communication with Starpharma.
Starpharma said it has requested a meeting with the FDA to discuss the data required.
The company will also discuss the next steps and any potential impact on its license with partner ITF Pharma which has the U.S. marketing rights for the medicine.
VivaGel BV, which is approved in the EU and Australia, has already received the infectious disease product and fast track designations from the FDA.