Starpharma’s HIV drug fast tracked by FDA

VivaGel is currently being developed as a vaginal microbicide gel to prevent the transmission of genital herpes and HIV. VivaGel was also recently awarded $20 million by the US-based NIAID, a division of the National Institutes of Health (NIH) to accelerate its development.

Under the fast track program, portions of the new drug application can be submitted to the FDA before the application is completed. This early review shortens FDA approval times significantly.

“VivaGel’s new drug application will receive priority review which has a shorter review time,” commented John Raff, CEO of Starpharma. “Fast Track status also provides more opportunity for Starpharma to communicate with the FDA to ensure the success of the VivaGel development program.”

With no cure currently available for HIV or genital herpes, and the limited success of existing prevention strategies, infection rates in the US and elsewhere are expected to continue to rise sharply.