If approved, the new formulation of DTG is expected to be the first integrase inhibitor offered as a dispersible tablet for children with HIV
Image: GlaxoSmithKline head office, in London, UK. Photo: Courtesy of Ian Wilson/Wikipedia.
ViiV Healthcare, a joint venture between GSK, Pfizer and Shionogi, has filed regulatory submissions with the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) for approval of dolutegravir (DTG).
DTG has been submitted for regulatory approval, in a 5mg dispersible-tablet (DT) formulation, along with a simplified dosing regimen to enhance use of the existing DTG 50mg film-coated tablet (FCT) in paediatric HIV patients.
ViiV Healthcare CEO Deborah Waterhouse 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.”
Dolutegravir is an integrase strand transfer inhibitor (INSTI) intended for use in combination with antiretroviral (ARV) agents for the treatment of HIV.
The drug binds to the integrase active site and inhibits the HIV integrase by blocking the strand transfer step of retroviral DNA integration, an essential step in the HIV replication cycle.
Data from P1093 and ODYSSEY clinical studies of DTG supported the regulatory submissions
P1093 was designed to evaluate the safety, pharmacokinetic, tolerability and antiviral activity of DTG regimens in paediatric patients aged four weeks to 18 years, while ODYSSEY is designed to assess the DTG, compared to the current standards of care in paediatric patients aged four weeks to 18 years.
ViiV Healthcare has conducted the clinical studies in collaboration with the US National Institutes of Health (NIH), the International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT) and the Paediatric European Network for Treatment of AIDS (PENTA) for ODYSSEY.
In addition, it has joined forces with the Clinton Health Access Initiative (CHAI) and Unitaid to advance the development and launch of DTG in optimised paediatric formulations, offering financial and technical support for the development and manufacture of the drug.
Stony Brook Children’s Hospital paediatrics professor Sharon Nachman said: “It is always a significant achievement when we get to the stage where data from our trials is shared with regulatory authorities. Collaborating with ViiV Healthcare on the P1093 study has given us the opportunity to be involved with the progression of a new dispersible treatment option for children living with HIV.
“With relatively few therapies licensed to treat HIV in children, the availability of dolutegravir in this new formulation will allow us to expand our choice of antiretrovirals, taking us another step closer to our ultimate goal of achieving an AIDS-Free Generation.”