The US Food and Drug Administration (FDA) has granted qualified infectious disease product (QIDP) and fast track designation for Australian-based Starpharma’s VivaGel treatment.
These designations were granted independently for both the VivaGel treatment and prevention indications for bacterial vaginosis (BV).
They have been designed to make new therapeutics available to patients soon, carrying benefits for regulatory approval and commercialisation of VivaGel BV.
Starpharma CEO Dr Jackie Fairley said: “This is a very positive commercial development, which expedites the path to US market entry for VivaGel.
“VivaGel BV is understood to be the only product to receive such designations for both the BV treatment and prevention indications. The granting of QIDP and Fast Track status is important to accelerate access to VivaGel BV for patients in the US that suffer from BV.”
Created by the Generating Antibiotic Incentives Now (GAIN) Act, QIDP designation provides incentives for the development of new antimicrobial products.
The incentives include priority regulatory review, as well as an additional market exclusivity of five years.
With the fast track designation in place, frequent interactions can take place with the FDA for faster approval.
At present, VivaGel BV is being evaluated through two Phase III clinical studies.
In October last year, patient enrolment in the programme was completed, and the trials are expected to conclude in the first quarter of this year.
Starpharma is also planning to submit a marketing application for VivaGel BV to the FDA soon.
Image: VivaGel BV is currently being evaluated through two Phase III clinical studies. Photo: © Starpharma Holdings.