Posted by Michael Wonder on 28 Dec 2018
US FDA requests further data for VivaGel BV approval
27 December 2018 - Regulatory processes underway continue in other markets and are independent of FDA approval.
Starpharma today received advice from the US FDA that it will require confirmatory clinical data prior to approving VivaGel BV for treatment of bacterial vaginosis and the prevention of recurrent BV.
Starpharma is currently evaluating the details of FDA’s advice but anticipates being able to address the issues raised through the generation of confirmatory clinical efficacy data. The company is requesting a meeting with the FDA as soon as practicable to discuss the data required and Starpharma is keen to secure approval with minimal delay. Encouragingly, the FDA did not identify any approvability issues in relation to the safety, manufacturing or quality of VivaGel BV. Starpharma will also be discussing next steps with its US partner, ITF Pharma, and any potential impact on its US licence.
