ViiV Healthcare Receives FDA Approval for a Drug to Treat Infants and Children with HIV
ViiV Healthcare, the company majority-owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, announced that the US Food and Drug Administration (FDA) has approved Tivicay PD (dolutegravir) tablets for oral suspension, which are used in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in paediatric patients (treatment-naïve or -experienced but INSTI- naïve) aged at least four weeks and weighing at least 3kg, as well as an extended indication to expand the use of the already approved Tivicay (dolutegravir) 50mg film-coated tablet in paediatric HIV patients weighing 20kg and above.
Deborah Waterhouse, CEO of ViiV Healthcare said, “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. 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.”
Dolutegravir is an 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.
Chip Lyons, President and CEO of the Elizabeth Glaser Pediatric AIDS Foundation (EGPAF) said, “Children are often forgotten in the global fight to end HIV/AIDS and face a unique set of challenges, particularly when HIV medication and treatments are often hard to swallow or tolerate. Barriers like these have resulted in only half of the 1.7 million children living with HIV accessing the lifesaving treatment they need—and even fewer still reaching viral suppression. Families affected by HIV will benefit from ViiV Healthcare’s development of child-friendly formulations that aim to close the gap between treatment options available for adults and children. This tailored approach to paediatric treatment of HIV will help meet the urgent needs of this vulnerable population.”
Tivicay PD and the extended indication of the existing Tivicay 50mg film-coated tablet are both currently under review by the European Medicines Agency (EMA).
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