Starpharma Holdings Ltd. announced it has been granted Qualified Infectious Disease Product (QIDP) and Fast Track designation for VivaGel® BV by the US Food and Drug Administration (FDA). QIDP and Fast Track designations were granted independently for both the VivaGel® BV treatment and prevention indications for bacterial vaginosis (BV). This positive 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 USD 1 billion globally. These two important 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.