LEO Pharma seeks EU label expansion for Anzupgo in adolescents with chronic hand eczema
The proposed expansion would allow its use in adolescents aged 12 to 17 years with moderate to severe chronic hand eczema (CHE) when topical corticosteroids are inadequate or inappropriate.
DENMARK—LEO Pharma A/S has announced that the Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending an extension of the European Union (EU) marketing authorisation for Anzupgo® (delgocitinib) cream.
The proposed expansion would allow its use in adolescents aged 12 to 17 years with moderate to severe chronic hand eczema (CHE) when topical corticosteroids are inadequate or inappropriate.
The recommendation brings the company closer to making Anzupgo available to adolescent patients in the EU.
The European Commission will make the final decision on the proposed label expansion.
Addressing an unmet need
Sophie Lamle, Executive Vice President of Development at LEO Pharma, said the positive CHMP opinion represents an important step toward providing adolescents with an additional treatment option for chronic hand eczema.
“Chronic hand eczema can have a significant impact on young people’s daily lives,” Lamle said, noting that the condition can affect psychosocial well-being, school performance, and participation in leisure activities.
Adolescents with CHE may experience itching, pain, blistering, and swelling, with symptoms affecting their ability to carry out everyday activities.
Because the disease can recur through repeated flares, it can also create a wider burden for patients and their families, including effects on social confidence and caregiver well-being.
LEO Pharma said treatment options specifically approved for adolescents with CHE remain limited in the EU.
Topical corticosteroids may also be inadequate or inappropriate for some patients, highlighting the need for other non-steroidal topical treatments.
Phase 3 trial supports application
The positive CHMP opinion is supported by findings from DELTA TEEN, a 16-week, phase 3, randomized, double-blind, vehicle-controlled, parallel-group, multi-site trial.
The study evaluated twice-daily applications of Anzupgo cream against a vehicle cream in adolescents aged 12 to 17 years with moderate to severe CHE for whom topical corticosteroids were inadequate or inappropriate.
Researchers assessed treatment success using the Investigator’s Global Assessment for Chronic Hand Eczema (IGA CHE) at Week 16.
Treatment success was defined as an IGA CHE score of 0, indicating clear skin, or 1, indicating almost clear skin, together with at least a two-step improvement from baseline.
According to LEO Pharma, the trial met its primary endpoint as well as its key secondary endpoints.
Current approvals
Anzupgo is currently approved in the EU for adults with moderate to severe CHE when topical corticosteroids are inadequate or inappropriate.
The treatment also has regulatory approval for adult patients with CHE in several other markets, including the United Kingdom, Switzerland, Canada, Australia, South Korea, and the United States.
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