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Cabenuva allows virologically suppressed adults living with HIV without prior treatment failure or resistance to cabotegravir or rilpivirine to maintain viral suppression with 12 dosing days per year
ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc ( GSK ), with Pfizer Inc. and Shionogi Limited as shareholders, today announced that the US Food and Drug Administration (FDA) approved Cabenuva, 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 (ARV) regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per milliliter [mL]) on a stable regimen, with no history of treatment failure, and with no known or suspected resistance to either cabotegravir or rilpivirine. Prior to initiati
Published: Dec 24, 2020 By Alex Keown
The European Union (EU) authorized
ViiV Healthcare’s Vocabria (cabotegravir injection and tablets) in conjunction with Janssen’s Edurant (rilpivirine tablets) for the treatment of HIV-1 infection in adults who are virologically suppressed. Vocabria is intended for adults who are virologically suppressed on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the NNRTI and INI class. The approval of ViiV’s treatment is the first time HIV-1 patients in Europe may be able to receive a long-acting injectable treatment that removes the need to take daily oral tablets, following the oral initiation phase.
GlaxoSmithKline PLC (NYSE:GSK), Johnson & Johnson (NYSE:JNJ) - GlaxoSmithKline s ViiV Healthcare Bags EU Marketing Authorization For Long-Acting HIV Treatment benzinga.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from benzinga.com Daily Mail and Mail on Sunday newspapers.
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GlaxoSmithKline plc (LON:GSK), with Pfizer Inc. and Shionogi Limited as shareholders, has announced ViiV Healthcare, the global specialist HIV company, announced the authorisation of Vocabria (cabotegravir injection and tablets) in combination with Janssen Pharmaceutical Companies of Johnson & Johnson’s Rekambys (rilpivirine injection) and Edurant (rilpivirine tablets), in the European Union, for the treatment of HIV-1 infection in adults who are virologically suppressed. Cabotegravir injection is indicated, in combination with rilpivirine injection, for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults who are virologically suppressed (HIV-1 RNA
Janssen Announces European Commission Authorisation of the First Complete Long-Acting Injectable HIV Treatment in Europe businesswire.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from businesswire.com Daily Mail and Mail on Sunday newspapers.