Sunlenca (lenacapavir)
- Region
- 🇪🇺 EU
- Active substance
- lenacapavir
- Company
- Gilead Sciences Ireland Unlimited Company
- Status
- Authorised
- Therapeutic area
- HIV Infections
- CHMP opinion
- Thu 23 Jun 2022
- EU approval
- Wed 17 Aug 2022
- Designations
- Additional monitoring
- Application
- EMEA/H/C/005638
- ATC
- J05AX
- Official record
- www.ema.europa.eu
Indication
Sunlenca injection, in combination with other antiretroviral(s), is indicated for the treatment of adults with multidrug resistant HIV 1 infection for whom it is otherwise not possible to construct a suppressive anti viral regimen (see sections 4.2 and 5.1). Sunlenca tablet, in combination with other antiretroviral(s), is indicated for the treatment of adults with multidrug resistant HIV 1 infection for whom it is otherwise not possible to construct a suppressive anti viral regimen, for oral loading prior to administration of long-acting lenacapavir injection (see sections 4.2 and 5.1).
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇺🇸 Bixlenvo Approved · Gilead Sciences Inc
- 🇪🇺 Yeytuo Authorised · Gilead Sciences Ireland Unlimited Company
- 🇺🇸 Bixlenvo Sunlenca Starter Pack (Copackaged) Approved · Gilead Sciences Inc
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.