Long-acting HIV-1 treatment may remove need for daily therapy
ViiV Healthcare has received Marketing Authorisation for the first complete long-acting injectable HIV treatment in Europe.
Marketing Authorisation has been granted by the European Commission for ViiV Healthcare’s Vocabria (cabotegravir injection and tablets) to be used with Janssen’s Rekambys (rilpivirine injection) and Edurant (rilpivirine tablets).
The long-acting injectable regimen was preferred by the majority of clinical trial patients who tried the treatment over their previous daily oral therapy.
ViiV Healthcare, owned by GlaxoSmithKline plc (GSK), with Pfizer Inc. and Shionogi Limited as shareholders, announced the authorisation of the new treatment in the European Union (EU), for the treatment of HIV-1 infection in combination with Janssen Pharmaceutical Companies of Johnson & Johnson’s Rekambys (rilpivirine injection) and Edurant (rilpivirine tablets), in the EU, for the treatment of HIV-1 infection in
The FDA has approved cabenuva, which consists of rilpivirine and cabotegravir, for treating HIV-1 infection in adults. This therapy is the first once-monthly, long-acting injectable to be approved for the treatment of HIV.
GSK: ViiV Healthcare Gets FDA Approval For HIV Treatment Cabenuva
LONDON (dpa-AFX) - GlaxoSmithKline plc (GSK, GSK.L) said Friday that its majority-owned specialist HIV company ViiV Healthcare has received approval from the US Food and Drug Administration for Cabenuva (cabotegravir, rilpivirine), the first and only complete long-acting regimen for the treatment of HIV-1 infection in adults.
Cabenuva is provided as a co-pack with two injectable medicines - ViiV Healthcare s cabotegravir and Janssen s rilpivirine - dosed once monthly, as an option to replace the current antiretroviral or ARV regimen.
The treatment is taken in those who are virologically suppressed on a stable regimen, with no history of treatment failure, and with no known or suspected resistance to either cabotegravir or rilpivirine.
Share this article
Share this article
TITUSVILLE, N.J., Jan. 21, 2021 /PRNewswire/ The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. Food and Drug Administration (FDA) has approved CABENUVA (consisting of Janssen s rilpivirine and ViiV Healthcare s cabotegravir), the first and only once-monthly, long-acting regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults. The novel regimen was co-developed as part of a collaboration with ViiV Healthcare and builds on Janssen s 25-year commitment to make HIV history. In the U.S., ViiV Healthcare is the marketing authorization holder for CABENUVA.
CABENUVA is indicated as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen, with no history of treatment failure, and with no known or suspected resist