Lenacapavir gets positive opinion for approval in the EU to treat MDR HIV
Simon Collins, HIV i-Base
On 24 June 2022, the CHMP recommended EU approval for lenacapavir as a treatment for people with multiple drug resistance to other HIV drugs. 
This is based on 26-week results from the CAPELLA study that were recently published in the NEJM (and presented at CROI 2022 and EACS 2021). 
Lenacapavir is a capsid inhibitor given by subcutaneous injection every six months.
Positive opinions from the CHMP are routinely given full approval in the EU within three months.
Lenacapavir needs to be used in combination with other HIV drugs that are active. As monotherapy, it has a low genetic barrier to drug resistance which will quickly lead to loss of this new class.
Cases of viral failure in the CAPELLA study resulted from low adherence to oral ART in the optimised background regimen.
A decision from the US FDA is also expected shortly as Gilead also announced that an issue relating to manufacturing and storage has also been resolved. [3, 4]
- Gilead press release. Investigational lenacapavir receives positive CHMP opinion for people with multi-drug resistant HIV. (24 June 2022).
- Lenacapavir in MDR HIV: phase 3 results of CAPELLA study published. HTB (! June 2022).
- Lenacapavir submitted to EMA for MDR HIV. HTB (17 September 2021).
- Gilead resubmits new drug application to US Food and Drug Administration for lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor. (27 June 2022).
This report was first published on 24 June 2022.