Starpharma (ASX:SPL) has been granted Qualified Infectious Disease Product (QIDP) and Fast Track designation for VivaGel BV by the US FDA.
QIDP and Fast Track designations were granted independently for both the VivaGel BV treatment and prevention indications for bacterial vaginosis (BV).
According to Starpharma, this development recognises the high unmet medical need in the management of BV and the potential of VivaGel BV to address that need for both treatment and prevention of recurrent BV, markets estimated to be worth in excess of US$1 billion globally.
These two designations are designed to make new therapeutics available to patients as rapidly as possible, carrying significant benefits for regulatory approval and commercialisation of VivaGel BV.
QIDP designation was created by the Generating Antibiotic Incentives Now (GAIN) Act, and provides incentives for the development of new antimicrobial products. These incentives include priority regulatory review and an additional five years’ of market exclusivity. The Fast Track designation enables more frequent interactions with the FDA and expedited review, leading to faster approval, and facilitates earlier market access for patients.
Starpharma CEO, Dr Jackie Fairley, said" “We are delighted that the FDA has granted VivaGel QIDP and Fast Track designation. This is a very positive commercial development which expedites the path to US market entry for VivaGel BV. 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.”