GSK: ViiV Healthcare's Vocabria Gets EU Approval To Be Used With Janssen's Rekambys And Edurant

(RTTNews) - GlaxoSmithKline plc (GSK, GSK.L) said Monday that its majority-owned specialist HIV company ViiV Healthcare has received the Marketing Authorisation for Vocabria (cabotegravir injection and tablets) in combination with Rekambys (rilpivirine injection) and Edurant (rilpivirine tablets), in the European Union.

Cabotegravir injection is indicated, in combination with rilpivirine injection for the treatment of Human Immunodeficiency Virus type 1 or HIV-1 infection in adults who are virologically suppressed.

The company said it is the first complete long-acting injectable HIV treatment approved in Europe, which removes the need to take daily oral tablets, following the oral initiation phase.

ViiV Healthcare's cabotegravir in combination with Janssen Pharmaceutical Companies of Johnson & Johnson's rilpivirine was co-developed as part of a collaboration with Janssen.

The marketing authorisation is based on the pivotal phase III ATLAS (Antiretroviral Therapy as Long-Acting Suppression), FLAIR (First Long-Acting Injectable Regimen) and ATLAS-2M studies, which included more than 1,200 participants from 16 countries.

Cabotegravir and rilpivirine are co-administered as two intramuscular injections in the buttocks by a Healthcare Professional at the same appointment. ViiV Healthcare is also owned by Pfizer Inc. and Shionogi Ltd.