21 October 2020 - - The European Medicines Agency has issued a positive opinion recommending Marketing Authorisation for Rekambys (rilpivirine injection) in combination with ViiV Healthcare's Vocabria (cabotegravir injection), for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults, US-based healthcare company Johnson and Johnson's (NYSE: JNJ) The Janssen Pharmaceutical Companies business said.

If approved, this 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 the European Economic Area.

The CHMP positive opinion is for co-administration of rilpivirine and cabotegravir injections for the treatment of HIV-1 infection in adults who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) and are on a stable antiretroviral regimen without present or past evidence of viral resistance or prior virological failure with agents of the non-nucleoside reverse transcriptase inhibitor (NNRTI) and integrase inhibitor class.

The CHMP opinion also included Janssen's Edurant (rilpivirine tablets) together with cabotegravir oral tablets for use as lead-in therapy for one month prior to the commencement of the long-acting injection regimen.

The EU-Marketing Authorisation Application for rilpivirine long-acting injections is based on the pivotal Phase 3 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 rilpivirine and cabotegravir, when injected intramuscularly once monthly, was as effective as continuing daily, oral, antiretroviral regimens in maintaining viral suppression throughout the 48-week study period.

In both studies, the most common adverse reactions (Grades 1 to 4) observed in ≥2% of participants receiving rilpivirine and cabotegravir 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 rilpivirine and cabotegravir due to adverse events.

The EU-MAA included 48-week data from the pivotal ATLAS-2M study to support the use of rilpivirine injections once every-2-months.

Results from the study showed the antiviral activity and safety of long-acting rilpivirine and cabotegravir injections administered once every-2-months was non-inferior to a once-monthly administration in virologically suppressed adults living with HIV-1 infection over a 48-week period.

In the ATLAS-2M study rates of serious adverse events (27/522 [5.2%]) and withdrawals due to adverse events (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 most common AEs were similar between once every-2-months and once a month injections.