The Committee deems that the clinical benefit of GIAPREZA 2.5 mg/ml (angiotensin II), concentrate for solution for infusion, is moderate in the Marketing Authorisation indication.
Clinical Added Value
no clinical added value
In view of:
the evidence of superiority of angiotensin II versus placebo in a phase III study (ATHOS-3) only on an intermediate outcome measure (increase in mean arterial pressure at 75 mmHg minimum or increase in relation to baseline of at least 10 mmHg 3 hours after setting up treatment), in addition to catecholamines and/or other vasopressors, in 321 adult distributive shock patients with refractory hypotension;
the lack of evidence of the efficacy of angiotensin II on mortality;
the lack of active comparator in the ATHOS-3 study, not allowing a positioning of angiotensin II compared to other available vasopressors in the therapeutic strategy;
an acceptable safety profile, but with identified adverse events (thromboembolic events and peripheral ischaemia) which entail close blood pressure monitoring, the use of concomitant prophylaxis of venous thromboembolic events and administration of the product at the lowest possible dose to achieve or maintain adequate mean arterial pressure and tissue perfusion;
a medical need for a therapeutic alternative in the treatment of refractory hypotension in cases of septic shock or other distributive shocks;
the Committee deems thatGIAPREZA 2.5 mg/ml (angiotensin II), concentrate for solution for infusion, provides no clinical added value (CAV V) in the current last-resort therapeutic strategy for the treatment of refractory hypotension in adults presenting with septic shock or any other distributive shock despite adequate vascular filling and after administering catecholamines and other available vasopressors.
Listen
