Novartis (NYSE:NVO) has obtained FDA approval for Rhapsido (remibrutinib), marking the first oral Bruton’s tyrosine kinase inhibitor (BTKi) for adults with chronic spontaneous urticaria (CSU) who continue to experience symptoms despite antihistamine therapy.
Rhapsido is a twice-daily oral pill that eliminates the need for injections or lab monitoring. It works by targeting BTK to block the release of histamine and other proinflammatory mediators, offering a novel mechanism to manage CSU.
“CSU is a serious disease that can cause debilitating symptoms and unpredictable flare-ups. It is challenging to diagnose and manage,” said Mark Lebwohl, MD, Dean of Clinical Therapeutics at the Icahn School of Medicine at Mount Sinai.
“Remibrutinib represents a new way to treat CSU. By blocking the activity of BTK, remibrutinib interrupts a key pathway of the immune response in CSU.”
In the U.S., CSU affects roughly 1.7 million people, with over half remaining symptomatic even after increased antihistamine doses. The condition causes recurring red, swollen, and itchy hives lasting six weeks or more without a known trigger, and diagnosis can take up to two years.
FDA approval was based on Phase III REMIX-1 and REMIX-2 trials, which showed Rhapsido’s superiority over placebo in reducing pruritus, urticaria, and weekly urticaria activity at Week 12. Patients receiving Rhapsido achieved meaningful disease control as early as Week 2, with about one-third experiencing complete resolution of symptoms by Week 12.
The most frequently reported side effects included nasal congestion, sore throat, runny nose, bleeding, headache, nausea, and abdominal pain.
Novartis has submitted Rhapsido for regulatory approval in multiple markets, including the EU, Japan, and China, with China granting priority review. Remibrutinib is also under investigation in trials for other immune-mediated conditions such as chronic inducible urticaria, hidradenitis suppurativa, and food allergies.
“This approval of Rhapsido as the first and only BTK inhibitor in CSU is an important milestone in our journey to redefine the treatment of neglected immune-related conditions and offer more patients the opportunity to find rapid relief,” said Victor Bultó, President, US, Novartis.