ViiV HC submits New Drug Application to US FDA for first monthly, injectable, two-drug regimen of cabotegravir and rilpivirine for treatment of HIV
Source: www.businesswire.com
ViiV Healthcare, the global specialist HIV company has submitted a New Drug Application to the US Food and Drug Administration (US FDA) seeking approval for an investigational, monthly, injectable, two-drug regimen of Rilpivirine and Cabotegravir for the treatment of HIV. ViiV Healthcare is majorly owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders. The submission is based on the global ATLAS (Antiretroviral Therapy as Long-Acting Suppression) and FLAIR (First Long-Acting Injectable Regimen) pivotal phase III studies that included more than 1,100 patients from 16 countries.
