CAB-LA receives positive opinion for EU approval as PrEP

1 August 2023. Related: Antiretrovirals, HIV prevention and transmission.

Simon Collins, HIV i-Base

On 24 July 2023, the European Medicine Agency (EMA) issued a positive opinion on approving long-acting cabotegravir injections (CAB-LA) and related oral tablets for HIV PreExposure Prophylaxis (PrEP). [1]

This is based on results from two large phase 3 international studies: HPTN 083 and 084 studies.

The indication will be to reduce the risk of sexually acquired HIV in adults and adolescents at high risk of infection, weighing at least 35 kg.

The US FDA approved CAB-LA PrEP in December 2021. As we noted then, price will determine the degree to which injectable PrEP will be accessed in Europe. [2]

In the UK, NICE are currently leading a scoping consultation for CAB-LA for PrEP, although it has not yet been approved by the MHRA. [3]

Source

1. ViiV press statement. ViiV Healthcare’s cabotegravir for HIV prevention receives positive CHMP opinion from European Medicines Agency. (24 July 2023).
   https://www.gsk.com/en-gb/media/press-releases/viiv-healthcare-s-cabotegravir-for-hiv-prevention-receives-positive-chmp-opinion-from-european-medicines-agency/
2. US FDA approves long-acting cabotegravir injections for PrEP: price set at $22,000 a year. HTB December 2021.
   https://i-base.info/htb/41890
3. Cabotegravir injections for preventing HIV-1 in adults and young people ID6255.
   https://www.nice.org.uk/guidance/indevelopment/gid-ta11304