Starpharma announced its US New Drug Application (NDA) 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 (QIDP) designation, which allows for rolling submission of the NDA and ensures priority regulatory review by the FDA.
FDA Fast Track status is designed to accelerate the regulatory process and secure rapid approval and early market access for products that address unmet medical needs. The QIDP designation applies to certain new antibacterial products and provides other significant commercial advantages such as an additional five years’ market exclusivity.
The rolling NDA submission for VivaGel BV is for both BV indications - BV treatment and prevention of recurrent BV (rBV). The NDA 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 finalized and will be submitted in the near future and then FDA review is expected to take approximately 6-8 months.
“We are delighted to be submitting our NDA for VivaGel BV. Starpharma is one of very few Australian companies to have achieved an NDA submission,” Dr Jackie Fairley, Starpharma CEO, said. “It is very satisfying strategically that we have retained the commercial rights to VivaGel BV, while developing the product from discovery through to the successful phase 3 trials and NDA submission – in doing so we’ve maximized its commercial value.”
Bacterial vaginosis is the most common cause of vaginal infection for women of childbearing age, and affects around 30% of women in the US. It is a highly recurrent condition with 50-60% of sufferers having it recurrently. BV is caused by an imbalance of naturally occurring bacterial flora. Smoking, the use of some hygiene products and several other risk factors are linked to a higher risk of developing BV.