Sanofi-Regeneron’s Dupixent gets FDA’s nod for skin condition
FDA clears Dupixent for chronic spontaneous urticaria in patients aged 12 and above, expanding its use in immune-related skin conditions
The U.S. Food and Drug Administration approved the use of Sanofi and Regeneron’s blockbuster drug Dupixent for patients with a type of skin condition, the two companies said on Friday.
The agency’s green light is a victory for the companies, as the FDA had declined to approve the drug for the skin condition in 2023 and had sought more efficacy data.
Dupixent is now cleared with allergy medication for patients aged 12 years and older with chronic spontaneous urticaria (CSU), a condition characterised by itchy rashes and swelling beneath the skin.
Both companies said they expect the target CSU patient population eligible for Dupixent to be more than 300,000 in the United States.
Sanofi last year recorded around 13 billion euros ($15 billion) in sales for Dupixent, which is already used for the treatment of immune system-related conditions such as asthma, eczema and a chronic lung condition in the U.S. and other countries.
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