Meeting highlights form CHMP June 2026: Recommendations on extensions of therapeutic indication for Symtuza

CHMP recommended extensions of indication to add a new strength of 675 mg/150 mg/ 20mg/ 10 mg filmcoated tablets grouped with an Extension of indication (C.I.6) to include treatment of human immunodeficiency virus type 1 (HIV 1) infection in paediatric patients (aged 6 years and older with body weight at least 25 kg) for SYMTUZA, based on the 24-week interim results from study GS-US-216-0128 (Cohort 2); this is a Phase II/III, multicentre, open-label, multicohort interventional study evaluating efficacy, safety, and pharmacokinetics of Cobicistat-boosted Atazanavir (ATV/co) or Cobicistat-boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in HIV-1 infected children. 

Additional information to the following link: https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-22-25-june-2026