Starpharma disclosed that the FDA will require confirmatory clinical data before it can approve VivaGel BV for the treatment of bacterial vaginosis (BV) and the prevention of recurrent BV. Chief executive Jackie Fairley said "clearly we are surprised and extremely disappointed with the FDA's requirement," with shares in the company falling nearly 30 percent on the news.
Last year, Starpharma filed a marketing application for VivaGel BV with the FDA through a rolling submission process, with the agency scheduled to make a decision in early January 2019. The application was based on data from two Phase III studies, which achieved their primary objective, with VivaGel BV demonstrating significant superiority compared to placebo in preventing recurrent BV. The filing also included earlier trial data on BV treatment.
Starpharma said that it is evaluating the FDA's response and will request a meeting with the agency "as soon as practicable to discuss the data required." Fairly added "importantly for the dendrimer component of VivaGel BV, which is the first of its kind to be reviewed by the FDA under [a new drug application], no issues were raised in relation to the safety, manufacturing or quality of the product."
According to Starpharma, it will also discuss next steps with its US partner, ITF Pharma, and any potential impact on the licensing deal. Starpharma has licensed VivaGel BV to Mundipharma for most regions outside the US. The product, a water-based vaginal gel for the treatment and prevention of BV, is currently approved in the EU and Australia, with initial launches planned during the first half of 2019.
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