Starpharma's VivaGel BV advances to next stage of FDA review

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Starpharma (ASX:SPL) says the US FDA has completed its filing review of the VivaGel BV New Drug Application (NDA).

"Confirmation by the FDA that the NDA has been accepted for filing is a significant regulatory milestone for Starpharma," said the company.

"This achievement reflects the completeness of the VivaGel BV data package and is expected to positively impact on licensing for the North American region, which is in the advanced stages of negotiation."

The company said the FDA had confirmed the VivaGel BV NDA will be the subject of a priority review. This has a target review period of approximately 6 months from acceptance.

Dr Jackie Fairley, Starpharma CEO, said: “We are extremely pleased to have achieved FDA’s acceptance and confirmation that the substantive review is now in progress. This is an important achievement for Starpharma and creates significant commercial value. It’s timely from a licensing perspective as this milestone will positively impact the advanced negotiations currently underway for the North American region – and we look forward to making an announcement shortly.”

VivaGel BV was granted QIDP and Fast Track status by the FDA. 

Fast Track status has accelerated the regulatory process for VivaGel BV and is intended to provide early market access for products that meet an unmet medical need.

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.