{"id":56054,"date":"2026-02-02T21:05:24","date_gmt":"2026-02-02T13:05:24","guid":{"rendered":"https:\/\/flcube.com\/?p=56054"},"modified":"2026-02-02T21:05:25","modified_gmt":"2026-02-02T13:05:25","slug":"sanofi-rezurock-wins-eu-backing-for-graft-versus-host-disease","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=56054","title":{"rendered":"Sanofi Rezurock Wins EU Backing for Graft\u2011Versus\u2011Host Disease"},"content":{"rendered":"\n

Sanofi<\/strong> (NASDAQ:\u202fSNY<\/a>) announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP)<\/strong> has recommended approval for Rezurock (belumosudil)<\/strong> in patients aged 12 and above<\/strong>, weighing at least 40kg<\/strong>, with chronic graft\u2011versus\u2011host disease (cGVHD)<\/strong> who have limited clinical benefit from, are ineligible for, or have exhausted other prior treatment options.<\/p>\n\n\n\n

Regulatory Milestone & Drug Status<\/h2>\n\n\n\n
Item<\/th>Detail<\/th><\/tr><\/thead>
Company<\/strong><\/td>Sanofi (NASDAQ:\u202fSNY)<\/td><\/tr>
Drug<\/strong><\/td>Rezurock (belumosudil)<\/td><\/tr>
Mechanism<\/strong><\/td>First\u2011in\u2011class selective ROCK2 inhibitor<\/td><\/tr>
Recommended Indication<\/strong><\/td>cGVHD in patients \u226512 years, \u226540kg<\/td><\/tr>
Regulatory Body<\/strong><\/td>EMA CHMP<\/td><\/tr>
Global Registration<\/strong><\/td>20 countries including US, UK, Canada<\/td><\/tr>
US Indication<\/strong><\/td>Failed \u22652 lines of therapy<\/td><\/tr>
China Indication<\/strong><\/td>Failed first\u2011line systemic therapy<\/td><\/tr>
Expansion Plans<\/strong><\/td>Exploring use in patients >1 year old and chronic lung allograft dysfunction<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Market Impact & Commercial Outlook<\/h2>\n\n\n\n