ViiV Announces Paediatric Dovato Marketing Applications to the EMA and FDA

ViiV Healthcare announced EMA validation and FDA submission to expand Dovato use into paediatric populations, beyond the current approval (≥12 years, ≥25 kg).

The applications include:

• a new dispersible formulation for children ≥3 months and ≥6 kg to <25 kg
• expansion of the existing tablet to patients ≥20 kg

Data are supported by bridging studies and the Phase 2/3 D3/Penta-21 trial.

If approved, the 2-drug regimen (2DR) could reduce long-term cumulative drug exposure in children on lifelong ART.

The initiative aligns with ViiV’s strategy to:

• expand Dovato across the full HIV treatment continuum
• strengthen positioning of INSTI-based 2DRs as simplified regimens

It also addresses a significant unmet need, with lower ART coverage in children vs adults.

Some considerations

• The filings are expected following recent clinical data and confirm ViiV’s lifecycle management strategy.
• They support expansion into younger paediatric segments despite expected LoE around 2029.
• Potential pediatric exclusivity extension remains uncertain.
• Overall, the move reinforces ViiV’s ambition to broaden 2DR use and improve access to child-friendly HIV treatments.