Sanofi gets EU orphan designation for rilzabrutinib

[Gratitude Concept With Heart Symbol]
Eoneren/E+ via Getty Images

* Sanofi (NASDAQ:SNY [https://seekingalpha.com/symbol/SNY]) (OTCPK:SNYNF [https://seekingalpha.com/symbol/SNYNF]) (GCVRZ [https://seekingalpha.com/symbol/GCVRZ]) announced that the European Medicines Agency (EMA) has given orphan designation to its experimental drug, rilzabrutinib, for the treatment of IgG4-related disease.
* Currently, rilzabrutinib is undergoing regulatory review in the United States, European Union, and China for its potential application in immune thrombocytopenia.
* The EMA's orphan designation [https://seekingalpha.com/pr/20200491-press-release-sanofi-s-rilzabrutinib-earns-orphan-designation-in-the-eu-for-igg4-related]is awarded to new therapies that target rare and serious medical conditions affecting fewer than 5 in 10,000 individuals in the EU.

MORE ON SANOFI

* Sanofi: Playing To Win [https://seekingalpha.com/article/4810298-sanofi-playing-to-win]
* Sanofi (SNY) Q2 2025 Earnings Call Transcript [https://seekingalpha.com/article/4807104-sanofi-sny-q2-2025-earnings-call-transcript]
* Sanofi 2025 Q2 - Results - Earnings Call Presentation [https://seekingalpha.com/article/4806870-sanofi-2025-q2-results-earnings-call-presentation]
* Trump pharma tariffs not imminent - report [https://seekingalpha.com/news/4485047-trump-pharma-tariffs-not-imminent]
* Sanofi reportedly halts sales of cholesterol drug Praluent in China amid limited availability [https://seekingalpha.com/news/4483935-sanofi-halts-china-sales-cholesterol-drug-praluent]