SUNLENCA (Gilead Sciences Pty Ltd)
Product name
SUNLENCA
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
139 (255 working days)
Active ingredients
lenacapavir sodium
Registration type
NCE/NBE
Indication
SUNLENCA, in combination with other antiretrovirals, 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.
Registration process
Priority review
Involves faster TGA evaluation of vital and life-saving medicines for which a complete data dossier is available