EMA issues positive opinion to approve cabotegravir LA/rilpivirine LA injections (Vocabria/Rekambys) as new HIV treatment

Simon Collins, HIV i-Base

On 16 October 2020, the European Medicines Agency (EMA) published a positive opinion to approve long-acting injections of cabotegravir and rilpivirine as a new HIV treatment. [1, 2]

This decision has also been long-awaited as submission to the EMA was made in July 2019. [3]

Cabotegravir is an integrase inhibitor and rilipivirine is an NNRTI, and long acting intramuscular injections are given concurrently, rather than in the same formulation. Rilpivirine LA requires cold-chain storage.

Although approval was largely based on results from three phase 3 studies using monthly injections, the EMA decision includes the option to use either monthly or two-monthly dosing schedules. A lead-in phase using oral versions of both drugs is also required.

This recommendation from the EMA’s human medicines committee (CHMP) still has to be approved by the European Commission, but CHMP opinions are routinely adopted. However, discussions about price are not finalised until after full approval.

ViiV Healthcare developed cabotegravir LA and also led dual therapy with rilpvirine LA.

Trade names in the EU are Vocabria for cabotegravir LA injections and oral formulations and Rekambys for rilpivirine LA injections. Oral rilpivirine is already approved as Edurant.

In Canada (and probably in the US, though not yet approved by the FDA), the tradename for the dual injection is Cabenuva. This is because both injections are packaged together, whereas in the EU they will be packaged separately.

References

1. EMA. First long-acting injectable antiretroviral therapy for HIV recommended for approval. (15 October 2020).
   https://www.ema.europa.eu/en/news/first-long-acting-injectable-antiretroviral-therapy-hiv-recommended-approval
2. ViiV Healthcare. ViiV Healthcare receives positive CHMP opinion for long-acting regimen for the treatment of HIV. (15 October 2020).
   https://viivhealthcare.com/en-gb/media/press-releases/2020/october/viiv-healthcare-receives-positive-chmp-opinion-for-long-acting-r
3. Cabotegravir/rilpivirine long-acting injectable HIV drugs submitted to EMA. HTB (23 August 2019).
   https://i-base.info/htb/36531

This report was first published online on 20 October 2020.