EMA approves Giapreza for hypotension in adults with septic shock.- La Jolla Pharmaceutical
The EMA has approved Giapreza (angiotensin II), from La Jolla Pharmaceutical, for the treatment of patients with refractory hypotension in adults with septic or other distributive shock. The full indication is for patients who remain hypotensive despite adequate volume restitution and application of catecholamines and other available vasopressor therapies.
The approval is based on data from the phase III ATHOS-3 study, which demonstrated the safety and efficacy of the drug in adults with septic or other distributive shock. In July 2019 the CHMP recommended granting a marketing authorisation for the drug for the treatment of refractory hypotension in adults with septic or other distributive shock. The FDA approves the drug for septic shock in December 2017.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
1 mins