ViiV Healthcare committed to deploy people, resources and technical expertise to speed up as much as possible the generation of data for regulatory approval of medicines for children living with HIV, including the ongoing development of Dolutegravir for children.
Sub-Actions & Milestones
Deploy people, resources and technical expertise to speed up as much as possible the generation of data for regulatory approval of medicines for children living with HIV, including the ongoing development of Dolutegravir for children.
Action 6: ViiV has committed additional resources to Pediatrics and has convened a cross‐functional team to address possible ways to accelerate development of DTG for pediatrics. Delivery against our commitments in paediatric HIV is a key objective
for ViiV globally.
Action 13: ViiV has appointed a Paediatric Medicines Development Lead (MDL) (Justin Green) who will further increase resource and focus in paediatrics. The MDL will work across the whole of ViiV’s R&D portfolio to bolster the portfolio approach to ViiV’s efforts in paediatric ARV development.
Action 18: ViiV had a productive meeting with the FDA in June 2018 to inform
clinical development plans and regulatory approach for paediatric DTG as planned.
Action 30: On 18 July 2018, ViiV and CHAI/Unitaid made a joint announcement to paediatric HIV stakeholders to announce the launch of a partnership to speed up
development and introduction of optimized pediatric formulations of dolutegravir for children living with HIV in resource‐limited settings. The initiative provides Mylan and Macleods (who both have voluntary licences for paediatric DTG through the Medicines Patent Pool) with a financial incentive award from Unitaid via CHAI, as
well as the technical expertise of ViiV Healthcare, to catalyze thedevelopment,
manufacture and supply of generic formulations of pediatric dolutegravir.