Starpharma ditches plans for US approval of bacterial vaginosis treatment

19 Feb 2024
firstwordpharma.com
Phase 3
Starpharma is giving up on obtaining approval of its bacterial vaginosis (BV) treatment in the US - at least for now - after the FDA upheld its call for further clinical data. CEO Cheryl Maley said “whilst we explore opportunities to enter the US market in the future, Starpharma will not prioritise conducting another VivaGel BV clinical trial.”
The FDA rejected VivaGel BV in 2018, asking for Starpharma to conduct a confirmatory study despite the application containing data from two Phase III studies that had achieved their primary objective. The company said Monday that as part of a formal dispute resolution process, it made multiple submissions to the agency, provided detailed analyses and regulatory precedents.
However, the FDA - which raised no approvability issues with the safety, toxicology, manufacturing or quality aspects of VivaGel BV - maintained its position on the need for another study. Maley explained that Starpharma “has carefully considered and taken account of numerous factors that could affect the outcome of the appeal, including complex regulatory and legal advice, a constantly evolving regulatory landscape, and relatively recent approvals of products used as regulatory precedents.”
The executive said the company will now focus on growing VivaGel BV’s sales in countries where it is already approved, including the UK, Europe, Southeast Asia, Australia and New Zealand.
More to come.
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