If approved, cabotegravir would be the first, long-acting therapy for HIV PrEP
LONDON--(BUSINESS WIRE)-- ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc (GSK), with Pfizer Inc. and Shionogi Limited as shareholders, today announced the initiation of a rolling submission of a new drug application (NDA) with the US Food and Drug Administration (FDA) for investigational, long-acting, injectable cabotegravir for the prevention of HIV, also called pre-exposure prophylaxis, or PrEP.
The rolling submission allows ViiV Healthcare to submit portions of the regulatory application to the FDA as they are completed, rather... More