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

Investing.com -- The drug rilzabrutinib, developed by Sanofi US Services Inc. (NASDAQ: SNY), 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.

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