La Jolla (LJPC) Secures Positive CHMP Opinion For Giapreza
Zacks Investment Research | Jul 01, 2019 08:39AM ET
La Jolla Pharmaceutical Company (NASDAQ:LJPC) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has rendered a positive opinion on Giapreza (angiotensin II) by recommending its marketing application in the drug’s favor to treat refractory hypotension in adult patients with septic or distributive shock.
Giapreza intravenous injection is already marketed in the United States as a vasoconstrictor, indicated to increase blood pressure in adult patients suffering septic or other distributive shock.
This CHMP’s response was based on data from the phase III ATHOS-3 study, which evaluated the safety and efficacy of Giapreza in the given patient population.
Notably, last June, the EMA validated the marketing authorization application (MAA) for Giapreza to treat critically ill patients afflicted with septic or distributive shock and subsequently, started the review process. If approved, Giapreza could be available in the EU market during early 2020 including Iceland, Norway and Liechtenstein.
Shares of La Jolla have dipped 1.9% so far this year against the Zacks Investment Research
Get The News You Want
Trading in financial instruments and/or cryptocurrencies involves high risks including the risk of losing some, or all, of your investment amount, and may not be suitable for all investors. Prices of cryptocurrencies are extremely volatile and may be affected by external factors such as financial, regulatory or political events. Trading on margin increases the financial risks.
Before deciding to trade in financial instrument or cryptocurrencies you should be fully informed of the risks and costs associated with trading the financial markets, carefully consider your investment objectives, level of experience, and risk appetite, and seek professional advice where needed.
Fusion Media would like to remind you that the data contained in this website is not necessarily real-time nor accurate. The data and prices on the website are not necessarily provided by any market or exchange, but may be provided by market makers, and so prices may not be accurate and may differ from the actual price at any given market, meaning prices are indicative and not appropriate for trading purposes. Fusion Media and any provider of the data contained in this website will not accept liability for any loss or damage as a result of your trading, or your reliance on the information contained within this website.
It is prohibited to use, store, reproduce, display, modify, transmit or distribute the data contained in this website without the explicit prior written permission of Fusion Media and/or the data provider. All intellectual property rights are reserved by the providers and/or the exchange providing the data contained in this website.
Fusion Media may be compensated by the advertisers that appear on the website, based on your interaction with the advertisements or advertisers.