Novartis Gains FDA Approval for First-in-Class Oral Hives Drug Rhapsido
The approval of the twice-daily pill remibrutinib positions the company to challenge injectable treatments in a multi-billion dollar market.
Novartis AG has secured a landmark U.S. Food and Drug Administration (FDA) approval for Rhapsido (remibrutinib), the first oral Bruton's tyrosine kinase (BTK) inhibitor for the treatment of chronic spontaneous urticaria (CSU), a severe form of chronic hives.
The approval marks a significant advancement for patients, offering a convenient twice-daily pill for a condition that has largely been treated with injectable biologics. The drug is cleared for adults whose condition is not adequately controlled by H1-antihistamine therapy, a population estimated to include over half of the 1.7 million people in the U.S. living with CSU.
This regulatory green light positions Novartis to compete directly with established injectable treatments like its own Xolair. Analysts have reacted positively, suggesting the convenience of an oral drug with a strong safety profile could disrupt the market. Many believe Rhapsido has , with sales forecasts exceeding $1 billion annually based on the chronic hives indication alone.
The global market for chronic spontaneous urticaria is substantial and projected to grow significantly, with some forecasts predicting it could reach nearly $5 billion by 2031. Novartis has priced Rhapsido at a wholesale acquisition cost of $4,521 for a 30-day supply, which the company states is in line with other branded therapies in the space.
According to , the approval was based on data from the pivotal REMIX-1 and REMIX-2 studies, which demonstrated clinically meaningful and statistically significant improvements in symptom control as early as two weeks after initiation. The drug's rapid onset and efficacy are expected to be key differentiators in the crowded immunology space.
Beyond chronic hives, Novartis is exploring remibrutinib's potential across a range of other immune-mediated conditions, including hidradenitis suppurativa, food allergy, and multiple sclerosis. This broad development program signals the company's strategy to maximize the asset's commercial potential, creating from a single molecule and further strengthening its robust immunology portfolio. Regulatory submissions for the drug have also been completed in the European Union, Japan, and China.