CHMP recommends approval of Vocabria in HIV.- ViiV HealthCare

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending marketing authorisation for Vocabria (cabotegravir injection and tablets), from ViiV HealthCare, in combination with Rekambys (rilpivirine injection) and Edurant (rilpivirine tablets), for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the non-nucleoside reverse transcriptase inhibitor (NNRTI) and integrase inhibitor (INI) class.The Marketing Authorisation Application (MAA) for cabotegravir injection and tablets is based on the pivotal phase III ATLAS (Antiretroviral Therapy as Long-Acting Suppression), FLAIR (First Long-Acting Injectable Regimen) and ATLAS-2M studies. The ATLAS and FLAIR studies included more than 1,100 participants from 16 countries. The studies demonstrated that cabotegravir and rilpivirine when injected intramuscularly in the buttocks, once-monthly, was as effective as continuing their daily, oral, antiretroviral regimens in maintaining viral suppression throughout the 48-week study period. The long-acting regimen was preferred by approximately 9 out of 10 patients who switched to cabotegravir and rilpivirine long-acting in the ATLAS and FLAIR studies over their previous daily oral therapy. In both studies, the most common adverse reactions (Grades 1 to 4) observed in at least 2% of participants receiving cabotegravir and rilpivirine were injection site reactions, pyrexia, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness, rash, and diarrhoea. Over the 48-week study period, a total of 4% of participants discontinued cabotegravir and rilpivirine due to adverse events. The 48-week data from the pivotal ATLAS-2M study were also included in the MAA to support the use of cabotegravir and rilpivirine once every 2-months. Results from the study showed the antiviral activity and safety of long-acting cabotegravir and rilpivirine injections administered once every 2-months was non-inferior to long-acting cabotegravir and rilpivirine injections administered once-monthly in virologically suppressed adults living with HIV-1 infection over a 48-week period.