Sanofi (SNY) Receives Orphan Designation for Rilzabrutinib

Sanofi (NASDAQ:SNY) is one of the Most Undervalued International Stocks According to Analysts. On August 14, Sanofi (NASDAQ:SNY) announced receiving an orphan designation for its Rilzabrutinib by the European Medicines Agency.

Rilzabrutinib is a reversible inhibitor targeting Bruton’s tyrosine kinase. The designation is for treating IgG4-related disease, which is a rare condition affecting fewer than 5 in 10,000 people in Europe. The designation was given after the treatment showed promising results in a Phase 2 clinical study, where patients treated for 52 weeks had fewer disease flares and improved markers. Moreover, the treatment also allowed reduced use of glucocorticoids, which are steroids with side effects.

Sanofi (SNY) Receives Orphan Designation for Rilzabrutinib

Dozens of pharmaceutical capsules piled on top of one another to show the scale of the company’s drug contributions to the industry.

Rilzabrutinib is under review by regulatory agencies in the US, EU, and China for ITP. The US FDA decision is expected by August 29, 2025.

Sanofi (NASDAQ:SNY) is a French healthcare company that researches, develops, manufactures, and markets medicines and vaccines.

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Disclosure: None. This article is originally published at Insider Monkey.