{"id":58323,"date":"2026-02-28T14:07:38","date_gmt":"2026-02-28T06:07:38","guid":{"rendered":"https:\/\/flcube.com\/?p=58323"},"modified":"2026-02-28T14:07:39","modified_gmt":"2026-02-28T06:07:39","slug":"novartis-remibrutinib-wins-chmp-positive-opinion-oral-btk-inhibitor-nears-eu-approval-for-chronic-urticaria","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=58323","title":{"rendered":"Novartis’ Remibrutinib Wins CHMP Positive Opinion \u2013 Oral BTK Inhibitor Nears EU Approval for Chronic Urticaria"},"content":{"rendered":"\n

Novartis<\/strong> (NYSE:\u202fNVS<\/a>) announced that the Committee for Medicinal Products for Human Use (CHMP)<\/strong> of the European Medicines Agency (EMA)<\/strong> has adopted a positive opinion<\/strong> recommending marketing authorization for remibrutinib<\/strong> as an oral treatment for chronic spontaneous urticaria (CSU)<\/strong> in adult patients with inadequate response to H1\u2011antihistamines<\/strong>. The European Commission (EC)<\/strong> is expected to issue a final decision within approximately two months<\/strong>, following prior approvals in the US and China<\/strong> under the brand name Rhapsido<\/strong>.<\/p>\n\n\n\n

Regulatory Milestone<\/h2>\n\n\n\n
Item<\/th>Detail<\/th><\/tr><\/thead>
Company<\/strong><\/td>Novartis (NYSE:\u202fNVS)<\/td><\/tr>
Product<\/strong><\/td>Remibrutinib (Rhapsido in US\/China)<\/td><\/tr>
Drug Class<\/strong><\/td>Highly selective oral BTK inhibitor<\/td><\/tr>
Regulatory Body<\/strong><\/td>EMA CHMP (positive opinion); EC (final decision pending)<\/td><\/tr>
Indication<\/strong><\/td>Chronic spontaneous urticaria (CSU)<\/td><\/tr>
Patient Population<\/strong><\/td>Adults with inadequate H1\u2011antihistamine response<\/td><\/tr>
Prior Approvals<\/strong><\/td>US and China (brand name: Rhapsido)<\/td><\/tr>
EU Timeline<\/strong><\/td>Final EC decision expected ~\u202f2 months<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Clinical Evidence \u2013 REMIX Phase III Trials<\/h2>\n\n\n\n
Endpoint<\/th>Remibrutinib Performance<\/th><\/tr><\/thead>
Onset of Action<\/strong><\/td>Improvements in itch and hives as early as Week\u202f1<\/strong><\/td><\/tr>
Sustained Efficacy<\/strong><\/td>Benefits maintained through Week\u202f52<\/strong><\/td><\/tr>
Quality of Life<\/strong><\/td>Early improvement observed<\/td><\/tr>
Sleep<\/strong><\/td>Early improvement observed<\/td><\/tr>
Safety\/Tolerability<\/strong><\/td>Well tolerated; no liver safety concerns<\/strong> through Week\u202f52<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Mechanism of Action<\/h2>\n\n\n\n
Component<\/th>Function<\/th><\/tr><\/thead>
Target<\/strong><\/td>BTK (Bruton’s tyrosine kinase)<\/strong><\/td><\/tr>
Pathway<\/strong><\/td>BTK\u2011mediated histamine release from mast cells<\/td><\/tr>
Mechanism<\/strong><\/td>Blocks BTK \u2192 reduces histamine release \u2192 relieves CSU symptoms (itch, hives)<\/td><\/tr>
Selectivity<\/strong><\/td>Highly selective BTK inhibition (vs. other kinases)<\/td><\/tr>
Administration<\/strong><\/td>Oral (convenience advantage vs. injectable biologics)<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Strategic Implications<\/h2>\n\n\n\n