GSK seeks licence to market baby-friendly HIV drug dolutegravir

British drugmaker GSK has applied for a licence to market its HIV drug dolutegravir in a formulation designed to be easier for babies and children who are living with the virus to swallow.
 
About 1.7 million children have HIV, most of them in sub-Saharan Africa, the United Nations agency UNAIDS says.
 
If approved by regulators, the medicine will be the first new generation HIV medicine available in baby-friendly form.
 

Doctors wanting to use dolutegravir in children with HIV have had no licenced child formulations, meaning they often have to prescribe older HIV medicines that can be less potent, harder for children to take, and have more side effects.

 
“Children in today’s world, still have fewer options in terms of HIV therapies compared to adults,” said Harmony Garges, chief medical officer for ViiV Healthcare, GSK’s HIV drugs division. She said she hoped the licence application would “enable approval of dolutegravir across the pediatric spectrum”.
 
ViiV’s CEO Deborah Waterhouse added in a statement: “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.”
 
Dolutegravir is a so-called integrase inhibitor and was originally developed by ViiV, in which Pfizer Inc and Shionogi & Co have small stakes. For the adult formulation, ViiV has already agreed licensing deals with generic companies to sell low-cost versions in poor countries.

 
New HIV infections among children have fallen by 41% since 2010, but there were 160,000 new cases in babies and children in 2018, and 100,000 children died of AIDS last year, partly due to lack of access to HIV medicines.