Sanofi’s Rilzabrutinib gets orphan designation by FDA for AIHA treatment

Published 20/02/2025, 18:14
© Reuters.

Investing.com -- The drug rilzabrutinib, developed by Sanofi (NASDAQ:SNY) US Services Inc., has been designated for the treatment of autoimmune hemolytic anemia (AIHA) on February 20, 2025 by the FDA. This designation, however, does not equate to FDA approval for this specific indication.

Rilzabrutinib is an oral, reversible, covalent BTK inhibitor. It has the potential to be a leading treatment for several immune-mediated and inflammatory diseases. BTK, found in B cells, macrophages, and other immune cells, plays a pivotal role in inflammatory pathways and various immune-mediated disease processes. Sanofi’s TAILORED COVALENCY® technology allows rilzabrutinib to selectively inhibit the BTK target, potentially reducing the risk of off-target side effects.

Sanofi US Services Inc., the sponsor of rilzabrutinib, is based in Bridgewater, New Jersey. The company is a global innovator in healthcare, dedicated to improving people’s lives through the pursuit of scientific miracles. Sanofi provides potentially life-altering treatment options and life-saving vaccine protection to millions of people worldwide. At the same time, the company places a strong emphasis on sustainability and social responsibility.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

Latest comments

Risk Disclosure: 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
© 2007-2025 - Fusion Media Limited. All Rights Reserved.