Key Takeaways
The European Commission approved Novartis AG’s Rhapsido for adults with chronic spontaneous urticaria (CSU), making it the first oral targeted treatment for a condition affecting nearly 4 million people in Europe.
"The approval of Rhapsido marks a major step forward, offering fast relief by blocking a key immune pathway, which may help a broad range of patients experience significant control of their disease,” Prof. Dr med. Martin Metz, Deputy Director at the Institute of Allergology, Charité Universitätsmedizin Berlin, said.
The approval is based on two Phase 3 trials, REMIX-1 and REMIX-2, which included 925 patients who had an inadequate response to H1-antihistamines. Remibrutinib, the drug's active compound, is a highly selective oral BTK inhibitor that blocks histamine release, a key driver of the itchy hives and swelling characteristic of CSU. More than 50% of patients on conventional antihistamine therapy continue to experience debilitating symptoms.
Rhapsido’s approval gives Novartis a first-mover advantage in the oral treatment market for CSU, a condition that impacts approximately 40 million people worldwide. The drug is taken twice daily and does not require lab monitoring, offering a convenient alternative to existing treatments. Rhapsido is already approved in the US and China.
CSU is a chronic skin condition characterized by the sudden appearance of itchy hives and/or deep tissue swelling for six weeks or longer, with no identifiable external trigger. The condition affects nearly twice as many women as men, most frequently between the ages of 20 and 40, and can cause significant physical and emotional distress, including sleep deprivation and anxiety.
The approval solidifies Novartis's position in the competitive immunology market and opens a significant new revenue stream. Investors will be watching for initial sales figures and further data from trials for expanded indications, including chronic inducible urticaria (CIndU), food allergy, and hidradenitis suppurativa (HS).
This article is for informational purposes only and does not constitute investment advice.
