EU regulator backs AstraZeneca drug for rare blood disorder in children
Reuters
Published Jul 26, 2021 07:46
(Reuters) - AstraZeneca (NASDAQ:AZN) said on Monday the European Medicines Agency (EMA) recommended approving a medicine from its U.S.-based Alexion (NASDAQ:ALXN) unit for treating a rare, deadly blood disorder in children and adolescents aged up to 18 years.
The drugmaker recently completed its $39-billion acquisition of Alexion, which it had agreed to buy as a bet on rare-disease immunology and to boost its business that includes a fast-growing cancer medicines unit and a major COVID-19 vaccine.
AstraZeneca said the drug Ultomiris had been given a positive opinion for paroxysmal nocturnal haemoglobinuria (PNH) by the human medicines committee of the EMA, and it follows a U.S. approval in June.
The EMA endorsement is to include children with a body weight of 10 kg or above, and those patients who are clinically stable after having been treated with another Alexion drug, Soliris, for at least the past six months.
"The potential approval of Ultomiris, which offers the efficacy and safety already established with Soliris (eculizumab) and requires fewer treatments each year, would have a meaningful impact for children with PNH and their families," said Austin Kulasekararaj, MD at King's College Hospital in London.
Ultomiris is an improved version of Alexion's best-selling drug Soliris, which is used against a range of rare immune-disorders including PNH where the body's immune system attacks its own red blood cells causing anaemia and blood clots.
Get The App
Written By: Reuters
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.