The FDA has approved a new drug called Rhapsido for adults with chronic spontaneous urticaria, often called CSU. This is a condition where hives and itching come back for weeks or months without a clear cause. Rhapsido is a kinase inhibitor, a type of medicine that calms part of the immune system. It is taken as a 25 mg pill twice a day, swallowed whole.
Rhapsido is only for adults whose symptoms are not well controlled with H1 antihistamines, the usual first treatment for hives. It is not approved for other types of urticaria. The approval is based on two large, year-long studies called REMIX-1 and REMIX-2. Together, they included 925 adults. At week 12, people taking Rhapsido had less itching and fewer hives than those taking a placebo.
This approval gives patients and doctors another option when antihistamines are not enough. It does not mean Rhapsido works for everyone or replaces standard care. Like all medicines, it has risks. For example, treatment should be paused for 3 to 7 days before and after surgery because of bleeding risk.
If you have ongoing hives, talk with your doctor about whether Rhapsido is right for you. Only a health care professional can decide if this medicine fits your situation.
