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ViiV Healthcare update on commitments regarding the clinical development and registration of age-appropriate formulations of dolutegravir for the treatment of HIV in infant and children
London, UK, 13 December 2018 - As part of ViiV Healthcare’s long-standing and ongoing commitment to addressing the challenges around the availability of optimal treatment for children living with HIV, we recently updated our partners and global organisations on our progress and future plans towards the collective global goal of achieving an AIDS-free generation, during the recent High-Level Dialogue on Paediatric HIV held at the Vatican, Rome on 6-7 December 2018.
Meaningful partnerships and engagement continue to be absolutely critical to our progress in generating clinical data as well as planning for successful, broad and sustainable access to paediatric DTG formulations.
Last month, we hosted our key clinical paediatric HIV partners from IMPAACT, PENTA, DAIDs, NIH and CHAI teams alongside the ViiV and GSK teams at our first ever joint regulatory submission planning meeting to lay strong foundations and establish a detailed plan for our next regulatory submissions.
Data generation continues to be a key priority for ViiV and the IMPAACT and PENTA networks as we all push hard to generate, analyse and format the remaining data that we need to develop the regulatory dossiers that will enable us to deliver on stringent regulatory authority expectations as quickly as possible.
So, whilst we are not there yet, we are getting close. We have set a very challenging target for this joint IMPAACT-PENTA-ViiV team to deliver FDA & EU regulatory submissions in December 2019. Specifically, these submissions will aim to optimise both the use of the 50mg DTG dose strength in children, as well as seek initial approval for our 5mg dispersible tablet formulation. There is still ongoing data generation, substantial analysis and formatting to deliver before that date, so achievement of this goal is not certain. However, as we progress through 2019, we will reach milestones that will help build our confidence that we can deliver on this stretch target together and we will continue to provide updates on our progress.
In parallel with the development of our own formulation of DTG, we also announced an important new joint initiative with CHAI/Unitaid and two generic manufacturers - Mylan and Macleods – in 2018 to expedite the development of generic formulations of paediatric DTG for developing countries. In 2019, we will continue to progress this initiative and to support novel approaches to interact with regulatory agencies to help us to deliver on our commitment – to deliver PADO-prioritised and optimised paediatric DTG formulations to children living with HIV as cost effectively and quickly as possible. Until generic formulations are available, ViiV Healthcare remains committed to registering our dispersible tablet formulation of DTG broadly where it is needed and to providing supply to public health programmes.
Beyond our medicines, ViiV Healthcare continues to play a strong role in supporting the community and healthcare service provision efforts to prevent new infections in neonates and adolescents, as well as to support and improve outcomes for children and their families, care-givers and communities affected by HIV through our Positive Action Programmes and our partnership with IAS on CIPHER.
More than ever ViiV Healthcare remains committed to drive momentum around the progress made over the past 12 months against our goals in paediatric HIV. Our commitment to the global community in this space will continue to be a key performance indicator for the whole ViiV Executive Team, the ViiV Board and our majority shareholder, GSK.
Click here for more information about our work in paediatric HIV care.