The US Food and Drug Administration today approved Giapreza (angiotensin II) injection for intravenous infusion to increase blood pressure in adults with septic or other distributive shock.
News of the approval sent the shares of the drug’s developer, La Jolla Pharmaceutical (Nasdaq: LJPC), rocketing 10.52% to $31.24.
“We appreciate FDA’s rapid review and approval of Giapreza and are especially grateful to the patients, families and dedicated critical care teams who made the development of Giapreza possible,” said George Tidmarsh, president and chief executive of La Jolla. “We look forward to bringing this new treatment option to the many critically ill patients suffering from septic or other distributive shock.”+
La Jolla plans to make Giapreza available for patients in the USA in March 2018. Analysts believe the drug could generate sales of half a billion dollars at peak.
Blood pressure is the force of blood pushing against the walls of the arteries as the heart pumps out blood. Hypotension is abnormally low blood pressure. Shock is a critical condition in which blood pressure drops so low that the brain, kidneys and other vital organs can’t receive enough blood flow to function properly.
In a clinical trial of 321 patients with shock and a critically low blood pressure, significantly more patients responded to treatment with Giapreza compared to those treated with placebo. Giapreza effectively increased blood pressure when added to conventional treatments used to raise blood pressure.
Giapreza can cause dangerous blood clots with serious consequences (clots in arteries and veins, including deep venous thrombosis); prophylactic treatment for blood clots should be used, according to the FDA.