FDA New Drug and Biologic Approvals -- 2017 Year-in-Review

Giapreza (synthetic human angiotensin II)

Indication:

Indicated to increase blood pressure in adults with septic or other distributive shock.

Mechanism:

Angiotensin II, the major bioactive component of the renin-angiotensin-aldosterone system (RAAS), serves as one of the body’s central regulators of blood pressure. It is a noncatecholamine vasopressor that raises blood pressure by vasoconstriction and increased aldosterone release. Direct action of angiotensin II on the vessel wall is mediated by binding to the protein-coupled angiotensin II receptor type 1 on vascular smooth muscle cells, which stimulates Ca2+/calmodulin-dependent phosphorylation of myosin and causes smooth muscle contraction.

Dosage:

Initial: 20 ng/kg/min IV by continuous infusion.

Titration: Monitor blood pressure response and titrate q5min by increments of up to 15 ng/kg/min prn to achieve or maintain target blood pressure; not to exceed 80 ng/kg/min during the first 3 hours of treatment.

Maintenance: Should not exceed 40 ng/kg/min; doses as low as 1.25 ng/kg/min may be used.

Approval:

Approval was based on the ATHOS-3 clinical trial (n=321) in patients with vasodilatory shock and critically low blood pressure. Significantly more patients responded to treatment with the angiotensin II injection compared with those treated with placebo. At 48 hours, the mean improvement in the cardiovascular Sequential Organ Failure Assessment (SOFA) score (scores range from 0 to 4, with higher scores indicating more severe dysfunction) was greater in the angiotensin II group than in the placebo group (P=0.01).

Reference:

Khanna A, et al. Angiotensin II for the Treatment of Vasodilatory Shock. N Engl J Med. 2017 Aug 3;377(5):419-430.

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Cite this: Mary L Windle. FDA New Drug and Biologic Approvals -- 2017 Year-in-Review - Medscape - Jan 11, 2018.