Shire's Filing Accepted By FDA For Gattex's Label Expansion
Zacks Investment Research | Nov 13, 2018 08:02PM ET
Shire plc (NASDAQ:SHPG) , the global leader in rare diseases, announced that the FDA has accepted for filing the company’s supplemental new drug application (sNDA) to expand the label of Gattex (teduglutide) for injection to pediatric patients (aged 1-17 years old) with Short Bowel Syndrome (SBS) who are dependent on parenteral support.
Gattex is already indicated for the treatment of adult patients with SBS who are dependent on parenteral support. Shire submitted the sNDA to the FDA on Sep 11, 2018. The FDA is expected to reach a decision in March 2019.
The application was supported by data from two completed phase III studies as well as interim data from two ongoing extension studies. Both the phase III studies evaluated the efficacy, safety, and pharmacodynamics of Gattex in children with SBS who were stable on their required parenteral nutrition (PN)/intravenous (IV) support that provided at least 30% of caloric and/or fluid/electrolyte needs for at least three months prior to screening.
Shares of the company have increased 16.6% year to date 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.