La Jolla Pharmaceutical Co. said the European Commission granted marketing approval to Giapreza for the treatment of certain adult patients with low blood pressure.
The European regulator gave marketing authorization for Giapreza, or angiotensin II, to treat refractory hypotension in adult patients with septic or other distributive shock who do not respond to other treatments. Refractory hypotension is a complication of a rare disorder, in which improper functioning of important glands in the body causes a deficiency of certain hormones.
The European Medicines Agency's Committee for Medicinal Products for Human Use, or CHMP, gave a positive opinion for the drug June 28.
The San Diego-based biotechnology company said the drug's approval is based on results from a phase 3 trial named Athos-3, which showed a statistically significant improvement in blood pressure response when compared to placebo. A trend of longer survival was also observed in the drug arm.
Giapreza is a synthetic formulation of a hormone present in the human body called angiotensin II. This hormone acts as a major blood pressure regulator in the body.
The U.S. Food and Drug Administration approved the drug in December 2017 to increase blood pressure in adults with septic or other distributive shock.
La Jolla entered into a financing deal with private equity firm HealthCare Royalty Partners in May 2018 to commercialize Giapreza worldwide.
