FDA approves drug to treat HIV infection in newborns

The US Food and Drug Administration (FDA) has approved Tivicay PD tablets for oral suspension (dolutegravir) to treat HIV infection in babies from birth up to four weeks weighing at least 2 kg, in combination with other antiretroviral agents. Tivicay and Tivicay PD were previously approved for adults and children older than four weeks.

Tivicay was developed and is marketed by ViiV Healthcare, the global specialist HIV company majority owned by UK pharma major GSK (LSE: GSK), with Japan’s Shionogi (TYO: 4507) as a shareholder. The company has not reported specific sales of the drug so far.