Lenacapavir submitted to EMA for MDR HIV
Simon Collins, HIV i-Base
On 19 August 2021, Gilead submitted data on lenacapavir to the EMA for a limited indication of treatment for HIV with multidrug resistance (MDR). 
The application is based on 26-week data from the phase 2/3 CAPELLA study.
Lenacapavir us given as a sub-cutaneous long-acting injection every six months.
The submission to the US FDA was in June 2021.
- Gilead press statement. European Medicines Agency validates Gilead’s marketing authorization application for lenacapavir, an investigational, long-acting capsid Inhibitor for the treatment of HIV-1 in people with limited therapy options. (19 August 2021).
- IAS 2021: lenacapavir studies show impressive results in naive, extensive drug resistance and potential as PrEP. HTB (August 2021).