ViiV Submitted Request to FDA and EMA for Dispersible Formulation of Dolutegravir

| By | EMA, FDA, New Drug Application, ViiV Healthcare

ViiV Healthcare, the global specialist HIV company majority-owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, announced it has made regulatory submissions to both the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) seeking approval of the first-ever 5mg dispersible-tablet (DT) formulation of dolutegravir (DTG), as well as a simplified dosing regimen to optimise use of the existing DTG 50mg film-coated tablet (FCT) in paediatric HIV patients. The availability of age-appropriate formulations is essential in ensuring children around the world have access to optimal life-saving treatments.

Paediatric HIV remains a global issue, with children disproportionately affected by the HIV epidemic. Latest statistics show 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 persist for 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.

Deborah Waterhouse, CEO of ViiV Healthcare, said: “For parents living in resource poor countries, the ability to give medicine to children in a format that they can swallow and tolerate can mean the difference between life and death. By submitting these files to regulators for approval, we believe that we are on the cusp of delivering against our promise to develop dolutegravir in a tablet that can be dispersed simply in water. We will then aim to make this available, via partnerships, as quickly as possible to children living with HIV worldwide.”

These submissions to the EMA and FDA are based on data from the ongoing P10934 and ODYSSEY (PENTA20) studies.5 Data to support the submissions has been generated from ViiV Healthcare’s collaborations with the U.S. National Institutes of Health (NIH) and the International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT) for P1093 and the Paediatric European Network for Treatment of AIDS (PENTA) for ODYSSEY.

In order to support 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, as well as some upper-middle-income countries through its voluntary licensing policy. In addition to this, ViiV Healthcare has partnered with the Clinton Health Access Initiative (CHAI) and Unitaid since 2018 to expedite the development and introduction of optimised paediatric formulations of DTG by providing generic partners with financial and technical incentives to develop and manufacture it for resource-limited settings.