Horizon Therapeutics Files BLA To FDA For Eye Disease Drug
Zacks Investment Research | Jul 10, 2019 09:05PM ET
Horizon Therapeutics plc ( (NASDAQ:HZNP) announced that it has submitted a Biologics License Application (BLA) to the FDA for its investigational medicine, teprotumumab, for the treatment of active thyroid eye disease (TED). The BLA submission is supported by results from the phase III confirmatory study, OPTIC, and positive phase II results. TED is a rare, autoimmune disease, in which the insulin-like growth factor receptor (IGF-1R) is overexpressed on eye tissues.
Results from the OPTIC study met the primary endpoint of improving proptosis or bulging of the eye compared to placebo. In the study, 82.9% of teprotumumab patients achieved the primary endpoint of a 2 mm or more reduction in proptosis compared to 9.5% of placebo patients. The study also successfully met secondary endpoints and the safety profile was consistent with the phase II study of the drug in TED. The confirmatory OPTIC study was initiated after clinically meaningful and highly statistically significant results from a phase II study, published in The New England Journal of Medicine on May 4, 2017.
Shares of the company have rallied 20.2% year to date compared with the Original post
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.