ViiV Healthcare Wins Approval in Europe for Tablets Treating HIV in Children
ViiV Healthcare has received EU approval for Tivicay (dolutegravir) in 5mg dispersible tablets, used in combination with other antiretrovirals for treating HIV in children at least four weeks old and weighing at least 6.6 lbs. (3 kg).
The approval was supported by positive results from two ongoing late-stage studies conducted in partnership with the global pediatric research groups, IMPAACT and PENTA-ID.
The new authorization also provides revised dosing recommendations for Tivicay in children six years and older and weighing at least 30.9 lbs. (14kg) to align with World Health Organization weight specifications.
The FDA approved Tivicay and Tivicay PD tablets in June 2020 for use with other antiretrovirals in treating children four weeks and older who weigh at least 6.61 pounds.