Novartis Secures FDA Approval for Rhapsido, a First-in-Class Oral Hives Drug
The approval marks the first oral Bruton's tyrosine kinase (BTK) inhibitor for chronic spontaneous urticaria, offering a new option for patients unresponsive to antihistamines.
Novartis (NVS) has received a significant boost to its immunology portfolio, announcing that the U.S. Food and Drug Administration (FDA) has approved Rhapsido (remibrutinib). The drug is a first-in-class oral treatment for adults with chronic spontaneous urticaria (CSU), a distressing skin condition commonly known as chronic hives. The approval introduces a novel and convenient therapeutic option for a patient population that has long struggled with symptoms that do not respond to conventional antihistamine treatments.
CSU is a debilitating condition characterized by the sudden appearance of itchy hives and swelling for six weeks or more without an identifiable cause. For many patients, first-line treatments like H1-antihistamines, even at higher doses, fail to provide adequate relief, creating a significant unmet medical need. Rhapsido operates as a highly selective Bruton's tyrosine kinase (BTK) inhibitor, targeting a key enzyme in the immune response pathway implicated in the release of histamine that drives the symptoms of CSU.
The regulatory green light is a direct result of positive outcomes from late-stage clinical trials. , the approval was based on robust data from Phase III studies that demonstrated the drug's efficacy and safety in controlling the persistent symptoms of the condition. As the first and only oral BTK inhibitor approved for CSU, Rhapsido offers a major advancement over existing therapies.
This approval positions Novartis to capture a key segment of the dermatology and immunology market. The introduction of an effective oral therapy provides a convenient alternative to injectable biologics, which can be a barrier for some patients. The commercial launch of Rhapsido is expected to strengthen Novartis's pipeline and contribute to its growth in specialty therapeutics, an area where the company has demonstrated consistent focus and success.
will be watching the market rollout of Rhapsido closely. The approval marks another regulatory victory for Novartis, which continues to successfully advance innovative, targeted treatments through its development pipeline. The launch of Rhapsido not only provides a much-needed new option for patients suffering from chronic hives but also reinforces Novartis’s strategic position as a leader in immunology and specialty medicine. The focus will now shift to the drug's commercial execution and uptake within the dermatology community.