Dec 13, 2019: ViiV Healthcare announced that it has made regulatory submissions to both the European Medicines Agency (EMA)Â and the U.S. Food and Drug Administration (FDA)Â in quest of approval of the first-ever 5mg dispersible-tablet (DT) formulation of dolutegravir (DTG), as well as a simplified dosing regimen in order to optimise the use of the existing DTG 50mg film-coated tablet (FCT) in paediatric HIV patients.
Paediatric HIV remains a global issue, with children suspiciously affected by the HIV epidemic. Latest statistics show that there are 1.7 million children living with HIV1, and the majority of AIDS-related deaths among children still occur during the first five years of life.
 Major obstacles keep on for the children, such as the availability of HIV testing, continued mother-to-child transmission, slow initiation of treatment and poor availability of optimised paediatric formulations of antiretrovirals.
These submissions to the EMA and FDA are based on the data from ongoing P10934 and ODYSSEY (PENTA20) studies.
Data to hold the submissions was generated from ViiV Healthcare’s collaborations by means of the U.S. National Institutes of Health (NIH) and the International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT) for P1093 and Paediatric European Network for Treatment of AIDS (PENTA) for ODYSSEY.
In order to maintain broad and more affordable access to optimised antiretroviral (ARV) formulations, ViiV Healthcare enables generic companies to manufacture and sell generic versions of paediatric DTG royalty-free in all least-developed, low-income, lower-middle-income and sub-Saharan African countries and also in some upper-middle-income countries through its voluntary licensing policy.
