GSK - ViiV announces new label update to streamline its HIV therapy in U.S.

ViiV Healthcare, owned by GlaxoSmithKline (NYSE:GSK) with Pfizer (NYSE:PFE) and Shionogi (OTCPK:SGIOF) (OTCPK:SGIOY), announced on Thursday that the US Food and Drug Administration (FDA) greenlighted a label update for its HIV medication, Cabenuva. The latest update has made the oral lead-in for the treatment optional, the company said. Cabenuva comprises cabotegravir and rilpivirine injections, a combined therapy co-developed with the Janssen unit of Johnson & Johnson (NYSE:JNJ). Previously, before the start of the therapy, the patients were required to receive oral cabotegravir and rilpivirine for a month, to test the tolerability of the injections. Based on a late-stage trial that indicated similar outcomes in patients with or without the oral lead-in, the FDA has approved a labeling change to make the oral phase of the treatment optional, the company said. “Today’s label update for the optional oral lead-in provides a streamlined initiation process for the regimen by allowing people to start

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ViiV announces new label update to streamline its HIV therapy in U.S.