FDA Expands Vemlidy Use to Adolescents With Chronic HBV

The US Food and Drug Administration has expanded the indication for tenofovir alafenamide to children aged 12 years and older with chronicThe approval in the pediatric patient population was supported by 24-week data from a phase 2 clinical trial comparing treatment with tenofovir alafenamide with placebo in 70 treatment-naïve and treatment-experienced patients aged 12 to < 18 years weighing at least 35 kg.

The study met its primary endpoint of percentage of patients with HBV DNA levels < 20 IU/mL at 24 weeks of therapy, Gilead said in aOverall, 10 of 47 patients treated with tenofovir alafenamide achieved HBV DNA < 20 IU/mL at 24 weeks compared with none of 23 treated with placebo. The rates of serum alanine aminotransferase normalization were higher with tenofovir alafenamide than with placebo .

The mean percent changes in bone mineral density from baseline to 24 weeks were numerically similar for tenofovir alafenamide- and placebo-treated patients . The mean changes from baseline BMD Z-scores were -0.03 and -0.09 for lumbar spine, and -0.05 and -0.01 for whole body, for tenofovir alafenamide and placebo groups, respectively.

Source: Law Daily Report (lawdailyreport.net)

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