Regulatory submissions made for dispersible formulation of dolutegravir

Regulatory submissions to both the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have been made by ViiV Healthcare 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, the company said.

Dolutegravir (Tivicay) is an integrase strand transfer inhibitor (INSTI) for use in combination with other antiretroviral (ARV) agents for the treatment of HIV. Integrase inhibitors inhibit HIV integrase by binding to the integrase active site and blocking the strand transfer step of retroviral deoxyribonucleic acid (DNA) integration which is essential for the HIV replication cycle.

“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,” said Deborah Waterhouse, CEO of ViiV Healthcare. “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. P1093 investigates the safety, pharmacokinetic, tolerability and antiviral activity of DTG regimens in paediatric patients aged four weeks to 18 years, while ODYSSEY is designed to understand how DTG as first- or second-line treatment compares to the current standards of care in paediatric patients aged four weeks to 18 years.