Gilead Sciences has received approval from the US Food and Drug Administration (FDA) to use Epclusa for treating chronic hepatitis C infection (HCV) in children aged six years and above.
Drug dose will depend on weight and liver function. Patients must weigh a minimum of 17kg for a prescription.
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Epclusa is a pan-genotypic, protease inhibitor-free regimen. The drug received the US and European regulatory approvals in 2016 to treat adults with hepatitis C infection.
Gilead Sciences chief medical officer Merdad Parsey said: “Gilead’s continued commitment to HCV elimination includes bringing our medicines to the most difficult-to-cure populations and today’s decision by the FDA represents an important step toward that goal.
“With consistently high cure rates in clinical trials and in the real world, Epclusa has the potential to help many of the children living with HCV in the US.”
The latest FDA approval comes after the review of results from a Phase II clinical trial performed in 175 children receiving Epclusa for 12 weeks.
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By GlobalDataEfficacy analysis in 173 participants showed a cure rate (SVR12) of 93% in children aged 12 to <18 years with genotype 1 HCV infection, 100% in those with genotype 2, 3, 4 and 6.
In patients aged six to <12 years old, the SVR rate was 93% in those with genotype 1, 91% in genotype 3, and 100% in genotype 2 and genotype 4 HCV infection.
The safety profile of the drug in children aged six years and above was generally consistent with trial data in adults.
With Gilead’s drug, the most common adverse reactions in adults are headache and fatigue.
Earlier this month, Gilead agreed to acquire Forty Seven for $4.9bn.
