The FDA has approved an oral pellet formulation of Gilead Sciences' hepatitis C drug Epclusa for use in young children who cannot swallow tablets. Gilead secured approval for two strengths of the formulation in children as young as three.
Epclusa, which contains the active ingredients sofosbuvir and velpatasvir, won FDA approval in the U.S. in adults in 2016. Gilead secured authorization to use the medicine in children aged six years and up who have chronic hepatitis C infection and weigh at least 17 kg last year. The approval provided physicians with a pan-genotype option for treating hepatitis C in children.
Now, the FDA has lowered the minimum age for Epclusa use again. To support dosing in children as young as three years, Gilead developed an oral pellet formulation of Epclusa that is designed to be easier to swallow than the tablets given to older people.
In children less than six years of age, the oral pellets are given once a day with food to increase the tolerability related to palatability. The prescribing information recommends sprinkling the pellets on one or more spoonfuls of non-acidic soft food such as pudding or chocolate syrup at or below room temperature. Gilead advises against chewing to avoid a bitter aftertaste.
Each dose of the oral pellets comes in an individual packet that needs to be shaken, cut or torn open, and sprinkled onto food or directly into the mouths of people aged six years and older. The pellets are available in two dosages to accommodate kids who weigh more or less than 17 kg.
Securing approval in children aged three years and up opens a new front for Gilead as it seeks to find growth opportunities for its hepatitis C franchise. Global sales of Epclusa and its authorized generic sold by Asegua Therapeutics fell by 19% last year. Even after suffering the drop, the aging blockbuster still generated $1.6 billion for Gilead, making it the cornerstone of the hepatitis C franchise.