The FDA just approved the popular drug Dupixent for adults and kids 12 and up with chronic spontaneous urticaria (CSU), a long-lasting itchy skin condition, when regular allergy meds don’t do the trick.

This is the seventh approved use for Dupixent and the first new targeted treatment in over a decade for the 300,000 people in the U.S. whose CSU isn’t well controlled. CSU is an inflammatory condition marked by raised, red, itchy bumps (hives) or welts on the skin that often come and go unexpectedly. The hives can affect any part of the body and typically last from 30 minutes to 24 hours. The exact cause is unknown, but it is linked to allergic reactions and an immune response known as type 2 inflammation – a process also seen in conditions like asthma and eczema. Antihistamines are often the first line of treatment, though they don’t work well for many people – highlighting the need for more targeted options.

“People with chronic spontaneous urticaria experience sudden, unpredictable hives and severe itch that cause a significant, and often overwhelming, burden on their everyday lives. The approval of this treatment offers patients more options and the chance to control their disease,” Kenneth Mendez, president and chief executive officer at the Asthma and Allergy Foundation of America, said in a news release from Sanofi, the drug’s maker.

The FDA’s decision came from two studies of 284 people, 12 and up, who still had symptoms after antihistamines and hadn’t tried other stronger options. After 24 weeks, patients taking Dupixent as an add-on to antihistamines had significant relief from itchiness and hives, compared with those who took antihistamines alone. And compared with a placebo, Dupixent helped more people get their condition under control or even clear up completely after 24 weeks. Developed by Sanofi and Regeneron and first approved in 2017, Dupixent (generic name, dupilumab) is a biologic that works by blocking certain pathways that add to type 2 inflammation, which plays a key role in CSU symptoms. Dupixent is available as a prefilled pen for shots under the skin and is used with standard antihistamines. After the first dose, it’s given every two weeks under a doctor’s guidance, either in a clinic or at home after training. For children ages 12 to 17, an adult should supervise the shots.