Type of information: Granting of a Market Authorisation in the US
Product name: Giapreza™
Compound: angiotensin II
Therapeutic area: Cardiovascular diseases - Infectious diseases
Company: La Jolla Pharmaceutical (USA - CA)
- increase of blood pressure in adults with septic or other distributive shock
- • On December 22, 2017, La Jolla Pharmaceutical announced that the FDA has approved Giapreza™ (angiotensin II) to increase blood pressure in adults with septic or other distributive shock. La Jolla plans to make Giapreza™ available for patients in the U.S. in March 2018.
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.
- This application received a Priority Review, under which the FDA’s goal is to take action on an application within six months when the agency determines that the drug, if approved, would significantly improve the safety or effectiveness of treating, diagnosing or preventing a serious condition.
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization: 2017-12-21
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: