The U.S. Food and Drug Administration (FDA) approved ViiV Healthcare’s Tivicay PD (dolutegravir) in combination with other antiretroviral drugs for children with HIV.
Tivicay got the approval.
The U.S. Food and Drug Administration (FDA) approved ViiV Healthcare’s Tivicay PD (dolutegravir) in combination with other antiretroviral drugs for children with HIV. ViiV Healthcare focuses on HIV. It is majority owned by GlaxoSmithKline with Pfizer and Shionogi as shareholders.
The drug was approved in children with HIV who are at least four weeks old and weigh at least 3 kilograms. The drug also received an extended indication to expand its use at the 50mg film-coated tablet in pediatric HIV patients that weigh 20kg or more.
“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, chief executive officer 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.”
Dolutegravir is the first integrase inhibitor available as a dispersible tablet designed to be dissolved in water for children as young as four weeks of age with a weight of at least 3kg. Before this, the drug was indicated in the U.S. for children six years and older that weighed more than 30kg.
ViiV has a voluntary licensing policy that allows generic versions of dolutegravir to be manufactured and sold royalty-free in all “least-developed, low-income, lower-middle-income and sub-Saharan Africa countries, as well as some upper-middle-income countries.” ViiV has worked with the Clinton Health Access Initiative (CHAI) and Unitaid since 2018 to expedite the development and introduction of better pediatric formulations of the drug for children most affected by HIV, with the most in sub-Saharan Africa.
As a result of the partnership, two generic drug companies have sub-licenses from the Medicines Patent Pool (MPP), Mylan Laboratories and Macleods Pharmaceuticals. Both received technical expertise from ViiV and a financial incentive from Unitaid via CHAI. Mylan recently hit a key milestone when it submitted a new drug application (NDA) for a scored dolutegravir 10mg dispersible tablet for tentative approval under the FDA President’s Emergency Plan for AIDS Relief (PEPFAR). Macleods expects to make its own submission soon.
Tivicay PD and the extended indication for the existing 50 mg film-coated tablet are under review by the European Medicines Agency (EMA).
“For babies and young children with HIV, getting treatment early is very important,” said Debra Birnkrant, director of the Division of Antivirals in the FDA’s Center for Drug Evaluation and Research. “While the incidence of pediatric HIV infections continues to decline, the availability and early initiation of effective treatment are critical for infants and children living with HIV. Tivicay and Tivicay PD are taken once daily, which could help patients and caregivers better adhere to the regimen. Today’s approval gives our youngest HIV patients more options, helping them live longer, healthier lives.”
At the end of 2016, according to the U.S. Centers for Disease Control and Prevention (CDC), there were 2,238 children younger than 13 years of age living with HIV in the U.S. There were 99 new HIV infections diagnosed in that age group in 2018. Globally, there are 1.7 million children living with HIV, with most AIDS-related deaths among children occurring in the first five years of life.
The approval of Tivicay and Tivicay PD were built on a clinical trial of 75 HIV-infected infants, children and adolescents four weeks to less than 18 years of age. The average age was 27 months. The trial found the Tivicay and Tivicay PD in pediatric patients comparable to adults on dolutegravir. At 24 weeks, 62% of children taking the drugs had an undetectable viral load and at 48 weeks, 69% had an undetectable viral load.
