21 November 2017 - Starpharma today announced that its US new drug application submission for VivaGel BV for both treatment and prevention of BV has been lodged with the FDA through a rolling submission process.

VivaGel BV has been granted fast track status and qualified infectious disease product designation, which allows for rolling submission of the NDA and ensures priority regulatory review by the FDA.

The rolling NDA submission for VivaGel BV is for both BV indications - BV treatment and prevention of recurrent BV (rBV). The application will feature data from the phase 3 trials for rBV reported in August 2017, as well as earlier trial data on BV treatment. The complete NDA will comprise five main data modules. The current submission includes three of the five main modules. Further modules are currently being finalised and will be submitted in the near future and then FDA review is expected to take approximately 6-8 months.

Read Starpharma press release