IMPAACT P1093 24-week data informs Committee for Medicinal Products for Human Use (CHMP) positive opinion to lower the age and weight limit for Tivicay® (dolutegravir) in children and adolescents living with HIV in Europe.
This CHMP positive opinion follows the U.S. Food and Drug Administration’s (FDA) paediatric approval in June 2016, of dolutegravir for a reduced age and weight limit. The CHMP has adopted a positive opinion on the Type II variation and extension applications to reduce the weight and age limit for the treatment of HIV in children and adolescents with Tivicay (dolutegravir) from at least 40kg to at least 15kg, in ages six to less than 12 years old, and to register new dose strengths of 10mg and 25mg oral tablets. This positive opinion is based on 24-week data from the Phase I/II multi-centre, open-label, P1093 study conducted in collaboration with the IMPAACT Network. IMPAACT P1093 is an ongoing, pharmacokinetic (PK), safety and efficacy study of dolutegravir plus optimised background regimen (OBR) in children and adolescents infected with HIV-1 in age-defined cohorts.
“We are very pleased at the determination of the CHMP to expand dolutegravir access for smaller children and are encouraged that this study is now rapidly enrolling younger children and infants to ultimately have approval down to 1 month of age”, said Andrew Wiznia, MD and Theodore Ruel, MD, IMPACT P1093 Protocol Co-chairs. “We thank the participants, the participating clinical sites and supportive staff for all their hard work and dedication in giving pediatric children access to this important antiretroviral.”
Read the full press release from ViiV.
Funded by the National Institute of Allergy and Infectious Diseases, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Institute of Mental Health of the US National Institutes of Health, US Department of Health and Human Services.