FDA expands approval for ViiV's Dovato to teens with HIV
08 Apr 2024
Phase 3Drug ApprovalClinical Result
ViiV Healthcare announced on Monday that the FDA approved Dovato (dolutegravir/lamivudine) for the treatment of certain adolescents with HIV-1 infection, making it the first oral, two-drug, single-tablet HIV regimen available for people as young as 12 years old.
Specifically, Dovato is now indicated for adolescents weighing at least 25kg with no prior antiretroviral (ARV) treatment or to replace the current ARV regimen in individuals who are virologically suppressed on an ARV regimen.
The broader indication provides "a complete HIV therapy with fewer ARV medicines – an important consideration for young people who will require lifelong treatment," said Lynn Baxter, who heads ViiV's North America operations.
The label expansion was supported by data from the DANCE study, which evaluated Dovato in treatment-naïve adolescents as well as three Phase III trials in adults with HIV, GEMINI-1, GEMINI-2 and TANGO. Results from the DANCE study showed that 26 of 30 participants achieved and maintained viral suppression at week 48, with safety and efficacy data comparable to those seen in adults.
For more details,please visit the original website
The content of the article does not represent any opinions of Synapse and its affiliated companies. If there is any copyright infringement or error, please contact us, and we will deal with it within 24 hours.
Indications
Targets
-Hot reports
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Leverages most recent intelligence information, enabling fullest potential.