Posted by Michael Wonder on 01 Jul 2019
La Jolla Pharmaceutical Company receives positive CHMP opinion for Giapreza (angiotensin II) for the treatment of refractory hypotension in adults with septic or other distributive shock
28 June 2019 - La Jolla Pharmaceutical Company today announced that the EMA's CHMP adopted a positive opinion for La Jolla’s marketing authorisation application for Giapreza (angiotensin II) for the treatment of refractory hypotension in adults with septic or other distributive shock.
The CHMP’s positive opinion is based on data from the ATHOS-3 (Angiotensin II for the Treatment of High-Output Shock) Phase 3 study, which established the safety and efficacy of Giapreza in adults with septic or other distributive shock.
The CHMP’s positive opinion will now be sent to the European Commission, which has the authority to approve medicines for the 28 European Union member countries. Approval would also be recognised in Iceland, Norway and Liechtenstein.
