FDA request more data for Starpharma's infection gel approval

Company News

by Rachael Jones

Biotech company Starpharma (ASX:SPL) has received advice from the US Food and Drug Administration that it will require more clinical data prior to approving VivaGel® BV for treatment of bacterial vaginosis.

Starpharma anticipates being able to address the issues raised.

The company is requesting a meeting with the FDA as soon as possible.

Starpharma will also be discussing next steps with its US partner, ITF Pharma, and any potential impact on its US licence.

VivaGel® BV is already approved in the EU and Australia, and regulatory processes currently underway continue in other markets and are completely independent of FDA approval.

Shares in Starpharma (ASX:SPL) closed 29.64 per cent lower at $0.98 yesterday.
 

Rachael Jones

Finance News Network
Rachael comes to FNN after working for Fairfax Media covering international breaking news, including the global economy and politics. She joined FNN in February 2018. She has reported on Australia’s finance news for various organisations since 2000 and has also interviewed a number of key business players, including Bill Gates. Rachael has also worked across a number of countries, including the UK and the US.