The European Commission has approved Dupixent (dupilumab) for adults and adolescents (12+) with moderate-to-severe chronic spontaneous urticaria who have not responded to H1 antihistamines and have not previously received anti-IgE therapy.
Eligible patients can use Dupixent as a first-line targeted treatment option.
The news comes two months after the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended EU approval for use of the drug.
“The unpredictable nature of chronic spontaneous urticaria leaves patients guessing when they’ll have their next outbreak of disruptive, debilitating hives and itch, which can make life challenging,” said Tonya Winders, President & CEO, Global Allergy & Airways Patient Platform.
“Dupixent is proven to reduce these intense symptoms and has the potential to make a positive impact on people struggling to control this disease.”
“Standard-of-care, first-line treatment options such as antihistamines offer limited relief for many people living with uncontrolled chronic spontaneous urticaria, leaving them to face unrelenting cycles of itch and hives,” said Dr Alyssa Johnsen, Global Therapeutic Area Head, Immunology Development at Sanofi.
“Dupixent significantly reduced these symptoms of CSU and led to more patients experiencing well-controlled disease or a complete response compared to placebo in two phase III studies."
"Now, eligible patients with CSU in the EU have a new option that is proven to reduce itch and hives.”
The approval is based on data from two phase III clinical studies in the LIBERTY-CUPID programme (NCT04180488).
Study A and Study C included 284 patients aged 12 years and older who were symptomatic despite the use of antihistamines and who were naïve to anti-IgE therapy.
Both studies assessed Dupixent as an add-on therapy to standard-of-care antihistamines compared to antihistamines alone and demonstrated that Dupixent significantly reduced urticaria activity (a composite of itch and hives) and individual measures of itch and hive severity compared to placebo at 24 weeks.
Dupixent also increased the percentage of patients with well-controlled disease and complete response at 24 weeks compared to placebo.
Study B (n=108) provided additional safety data and evaluated Dupixent in patients aged 12 years and older who were inadequate responders or intolerant to anti-IgE therapy and symptomatic despite antihistamine use.
Safety results from Study A, Study B and Study C were generally consistent with the known safety profile of Dupixent in its approved indications.
The most common adverse reactions to Dupixent include injection-site reactions, conjunctivitis, arthralgia, oral herpes and eosinophilia, with additional injection-site induration, dermatitis and haematoma reported in CSU studies.
In CSU patients, events occurring more often than with placebo (≥5%) included injection-site reactions, COVID-19, hypertension, CSU symptoms and accidental overdose.
“The approval of Dupixent for certain adults and adolescents with chronic spontaneous urticaria in the European Union represents the first innovation for patients with this disease in more than a decade,” said Dr George D. Yancopoulos, Board co-chair, President and Chief Scientific Officer at Regeneron.
“Physicians now have a new approach for CSU with Dupixent, as the only treatment that inhibits IL4 and IL13, two key drivers of type 2 inflammation and can offer patients significant improvement in debilitating itch and hives."
"This approval further demonstrates the ability of Dupixent to advance the treatment landscape for yet another chronic type 2 inflammatory disease, with a well-established safety profile across its indications.”
Beyond the EU, Dupixent is also approved for CSU in certain adults and adolescents in several countries, including the US and Japan.