ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today announced that 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) 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.

Deborah Waterhouse, CEO, ViiV Healthcare, said “Today’s positive CHMP opinion marks an important step in providing a new option that changes the treatment experience for people living with HIV across Europe. Vocabria injection used in combination with Rekambys has the potential to ease the day-to-day burden of HIV by offering significantly less frequent dosing from 365 days with oral regimens to 12 or 6 treatments per year.  Through our innovative R&D, we are now one step closer to offering an HIV medicine in Europe with a novel route of administration and dosing schedule compared to other therapies. We’re proud to be providing different treatment options that meet the diverse needs of the HIV community.”

If approved, cabotegravir injection used in combination with rilpivirine injection will be the first complete long-acting regimen, dosed once-monthly or once every 2-months, for virologically suppressed people living with HIV-1 across Europe. This treatment will offer people living with HIV an option with significantly less frequent dosing and comparable efficacy to daily oral regimens. Cabotegravir and rilpivirine injections are administered as two intramuscular (IM) injections in the buttocks during the same visit at a specialist clinic by a healthcare professional. Prior to the initiation of the injections, cabotegravir and rilpivirine oral tablets are taken for approximately one month (at least 28 days) to assess tolerability to the medicines. 

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 ≥ 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.

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.   In the ATLAS-2M study rates of serious adverse events (SAEs) (27/522 [5.2%]) and withdrawals due to adverse events (AEs) (12/522 [2.3%]) at 48 weeks were low and were similar to those experienced in the one month arm (SAEs: 19/523 [3.6%], withdrawals due to AEs 13/523 [2.5%]).

The Patient Reported Outcomes data from the ATLAS-2M study showed high levels of treatment satisfaction and acceptance, with 98% (n=300/306) of participants who were randomised to receive an oral lead-in followed by once every 2-months dosing preferring treatment once every 2-months compared to daily oral treatment (oral lead-in). Results indicate that administration frequency and convenience were the most common reasons for preferring treatment every 2-months.

ViiV Healthcare’s mission is to ensure that no one living with HIV is left behind. As the only pharmaceutical company solely focused on HIV and AIDS, ViiV Healthcare is working to deliver a broad range of treatments that meet the needs of a wide variety of people living with HIV (PLHIV). The company invest in R&D programmes that continuously push the boundaries to provide a portfolio of innovative treatment options that will help make a difference to the lives of PLHIV.  Cabotegravir and rilpivirine has been co-developed as part of a collaboration with Janssen Pharmaceutical Companies of Johnson & Johnson and builds on ViiV Healthcare’s industry leading portfolio, centred on delivering innovative medicines for the HIV community.

The CHMP positive opinion is one of the final steps before marketing authorisation is granted by the European Commission, which has the authority to approve medicines for use throughout the European Union. If approved, cabotegravir injection and tablets will be marketed as Vocabria to be used with Janssen’s Rekambys (rilpivirine injection) and Edurant (rilpivirine tablets).

Once-monthly dosing of cabotegravir and rilpivirine has been approved by Health Canada as a co-pack with two injectable medicines under the brand name Cabenuva, for the treatment of HIV-1 infection in adults who are virologically stable and suppressed. Vocabria (cabotegravir) oral tablets have also been approved by Health Canada. In July, ViiV Healthcare resubmitted the New Drug Application (NDA) for once-monthly dosing of cabotegravir and rilpivirine to the US Food and Drug Administration (FDA), and further regulatory applications have been submitted and are being reviewed by other regulatory bodies worldwide.