The VivaGel treatment manufactured by Australian company Starpharma has been granted qualified infectious disease product (QIDP) and fast track designation by the FDA in the United States.
Both the VivaGel treatment and prevention indications for Bacterial Vaginosis Clinical Trial received these designations independently.
VivaGel BV's commercialization and regulatory approval will benefit from their design, which aims to quickly make new therapeutics available to patients.
Dr. Jackie Fairley, CEO of Starpharma, said: This is a very encouraging commercial development that makes it easier for VivaGel to enter the US market.
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It is believed that only VivaGel BV has been granted these designations for both the treatment and prevention of BV. It is essential to grant QIDP and Fast Track status in order to expedite BV patients in the United States' access to VivaGel.
The QIDP designation, which was made possible by the Generating Antibiotic Incentives Now (GAIN) Act, gives incentives to make new antimicrobial products.
Priority regulatory review and an additional five-year period of market exclusivity are among the incentives.
In order to expedite approval, frequent interactions with the FDA under the fast track designation are possible.
VivaGel BV is currently the subject of two Phase III clinical studies.
Patient enrollment in the program was completed in October of last year, and the trials are anticipated to conclude in the first quarter of this year.
Additionally, Starpharma intends to soon submit a marketing application to the FDA for VivaGel BV.
