FDA Approves Dupixent for Treatment of Chronic Skin Condition

The U.S. Food and Drug Administration (FDA) recently approved Dupixent (dupilumab) for chronic spontaneous urticaria (CSU). This approval is for patients 12 years and older. CSU manifests as persistent, itchy skin featured by wheals or welts that are raised and red in hue. This approval allows patients who have not found relief from standard antihistamines to have access to an effective treatment option.

Dupixent works by blocking specific pathways that drive type 2 inflammation. This inflammation plays a major role in causing CSU. The medication is intended to be used alongside regular antihistamines, providing a multi-faceted approach to treating symptoms. The drug comes with a prefilled pen that makes it easy for patients to give themselves their own shots. With the right training, they can perform this work remotely from home or even a clinical space.

The FDA’s decision to approve Dupixent was based on two studies with 284 people over the age of 12. These patients were refractory to antihistamines and did not have treatment with more potent agents. These clinical responses were observed after 24 weeks of administration with improvement in itchiness and hives as reported by patients.

The partnership between Sanofi and Regeneron that created Dupixent took the drug through its first approval in 2017. This biologic has proved effective for a multitude of chronic inflammatory conditions such as asthma, eczema, chronic sinusitis with nasal polyps, eosinophilic esophagitis, prurigo nodularis and COPD. This newest approval increases its potential list of uses, giving hope to those afflicted with CSU.

Patients have their Dupixent injections taken every 2 weeks with a physician supervising it as opposed to self-administered. For adolescents 12–17 years, an adult must be present during the vaccine administration. Dupixent’s safety profile remains in line with earlier trials. While serious side effects can occur, a common side effect often involves localized reactions at the injection site.

Dupixent’s approval for chronic spontaneous urticaria marks an important new development in treatment choices for this difficult-to-manage condition. Patients now have access to a targeted therapy that can help alleviate their symptoms when traditional antihistamines alone are insufficient.