Takeda Pharmaceutical has received approval from the US Food and Drug Administration (FDA) for Edarbi tablets (azilsartan medoxomil) to treat hypertension in adults.
Results from clinical studies revealed that Edarbi was more effective at lowering 24-hour blood pressure compared to two other FDA-approved hypertension drugs, Diovan (valsartan) and Benicar (olmesartan).
Adverse events reported by patients taking Edarbi in the trial were similar to those reported by placebo receiving patients.
Edarbi tablets will be available in 40mg and 80mg doses, with the recommended dosage being 80mg once daily.
The 40mg dose will be indicated for patients who are treated with high-dose diuretics taken to lower salt in the body.
Edarbi is an angiotensin II receptor blocker that lowers blood pressure by blocking the action of angiotensin II, a vasopressor hormone.
Edarbi has a boxed warning stating that the use of the drug should be avoided in pregnant women, as the use of the drug during the second or third trimester can lead to the injury or death of the developing foetus.
