US approves ViiV’s dispersible dolutegravir for children with HIV

ViiV Healthcare has gained US approval for the first-ever dispersible tablet formulation of dolutegravir, Tivicay PD, a once-daily treatment for children living with HIV.

Dolutegravir is the first integrase inhibitor available as a dispersible tablet for oral suspension for children as young as four weeks of age and weighing at least 3kg.

Prior to this, dolutegravir was indicated in the US for children from six years of age and weighing more than 30kg.

This step will expand the use of dolutegravir by providing an age-appropriate formulation to a younger population and will help to close the gap between HIV treatment options available for adults and children.

The FDA approval is based on data from the ongoing P1093 and ODYSSEY (PENTA20) studies, which has been generated from ViiV Healthcare’s collaborations with the Division of AIDS (DAIDS) at the US 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) and the Medical Research Council (MRC) Clinical Trials Unit at University College London for ODYSSEY.

“I am delighted that our innovative approach to science has enabled us to achieve FDA approval of the first-ever dispersible tablet formulation of dolutegravir, now making it easier for young children to take this medication by dispersing the tablet in water,” said Deborah Waterhouse, CEO of ViiV Healthcare.

“The development and availability of age-appropriate formulations is essential in ensuring children have access to life-saving HIV treatments from an early age and as they grow. The support of our partners has been integral for this regulatory approval.

“We now need to continue our efforts to ensure this new dispersible formulation is available to children who need it around the world, in line with our mission to leave no person living with HIV behind.”

A message from the Editor:

Thank you for reading this story on our news site - please take a moment to read this important message:

As you know, our aim is to bring you, the reader, an editorially led news site but journalism costs money and we rely on advertising and digital revenues to help to support them.

With the Covid-19 lockdown having a major impact on our industry as a whole, the advertising revenues we normally receive, which helps us cover the cost of our journalists and this website, have been drastically affected.

As such we need your help. If you can support our news sites with a small donation of even £1, your generosity will help us weather the storm and continue in our quest to deliver quality journalism.

In the meantime may I wish you the very best.

- Advertisement -

FairJourney Biologics enters antibody discovery agreement with Pandion Therapeutics

FairJourney Biologics S.A (FJB) and IONTAS Limited (IONTAS), leaders in the discovery and optimization of VHH and fully human antibodies, have signed an agreement...

Beckman Coulter launch SARS-CoV-2 IgM antibody test in countries accepting CE Mark

Beckman Coulter, a clinical diagnostics leader, has announced the launch of its Access SARS-CoV-2 Immunoglobulin M (IgM) assay in countries accepting the CE Mark. The...

95% efficiency for Pfizer & BioNTech’s mRNA-based COVID vaccine candidate

Pfizer and BioNTech’s mRNA-based COVID-19 vaccine candidate – BNT162b2 – has achieved an efficiency rate of 95% after hitting all primary endpoints in a...

BMS completes $13bn MyoKardia acquisition

Bristol Myers Squibb (BMS) has completed its $13.1 billion acquisition of MyoKardia. “We are excited to welcome MyoKardia colleagues to Bristol Myers Squibb,” said BMS...

Samsung Biologics breaks ground on ‘world’s largest’ biopharma manufacturing facility

Samsung Biologics has officially begun construction of its Plant 4 in Incheon, South Korea. Dubbed the “Super Plant”, the new, multi-story 238,000-square-meter construction will be...

Related news

Regeneron’s antibody cocktail granted Emergency Use Authorisation

The FDA has granted Emergency Use Authorisation (EUA) to Regeneron’s antibody cocktail for COVID-19. The cocktail combines casirivimab and imdevimab administered together is the first...

FairJourney Biologics enters antibody discovery agreement with Pandion Therapeutics

FairJourney Biologics S.A (FJB) and IONTAS Limited (IONTAS), leaders in the discovery and optimization of VHH and fully human antibodies, have signed an agreement...

Beckman Coulter launch SARS-CoV-2 IgM antibody test in countries accepting CE Mark

Beckman Coulter, a clinical diagnostics leader, has announced the launch of its Access SARS-CoV-2 Immunoglobulin M (IgM) assay in countries accepting the CE Mark. The...

95% efficiency for Pfizer & BioNTech’s mRNA-based COVID vaccine candidate

Pfizer and BioNTech’s mRNA-based COVID-19 vaccine candidate – BNT162b2 – has achieved an efficiency rate of 95% after hitting all primary endpoints in a...