FDA issues CRL to ViiV Healthcare for cabotegravir and rilpivirine HIV regimen

America's health regulator issued a response at the start of the week to GlaxoSmithKline's application for an HIV-1 treatment for virologically suppressed adults from its ViiV Healthcare subsidiary.

According to the company, the so-called 'complete response letter' from the US Food and Drug Administration said no safety issues had been found relating to the manufacture and controls using its cabotegravir and rilpivirine inhibitors.

ViiV, a company specialised in HIV, is a joint-venture between Glaxo, Pfizer and Shionogi.