FDA Expands Approval of valsartan for Hypertension for children below 5 years

Study 2: In this study, researchers included 74 patients and found that higher doses (1 mg/kg and 4 mg/kg daily) of valsartan were associated with numerically greater blood pressure reductions than the lowest dose (0.25 mg/kg) at the end of 6- weeks treatment.

Study 3: It was a six weeks randomized study of 126 patients. The researchers observed dose-dependent reductions in mean systolic blood pressure (MSBP) with valsartan at week 6 (4.1mmHg with valsartan 0.25mg/kg and 8.5mmHg with valsartan 4mg/kg). Also, they noted that the CKD subgroup had reductions in MSBP with valsartan 4 mg/kg compared to 0.25 mg/kg (9.2 mmHg vs 1.2 mmHg).

Based on these findings the US FDA approved Diavon oral suspension, which is prepared using Diovan tablets for patients 1 to 5 years of age. Recommended starting dose is 1 mg/kg once daily Up to 40 mg daily. Recommended dose range is from 1-4 mg/kg once daily Up to 160 mg daily. The FDA noted that Diovan tablets and oral suspension are not substitutable on an mg-per-mg basis as the systemic exposure to valsartan is 60% higher with the suspension compared to tablets.

For further information:

https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021283s058lbl.pdf