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). [1]

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.

 References

1. 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).
   https://www.gilead.com/news-and-press/press-room/press-releases/2021/8/european-medicines-agency-validates-gileads-marketing-authorization-application-for-lenacapavir-an-investigational-longacting-capsid-inhibitor-for
2. IAS 2021: lenacapavir studies show impressive results in naive, extensive drug resistance and potential as PrEP. HTB (August 2021).
   https://i-base.info/htb/41003