European Medicines Agency recommends Anzupgo for chronic hand eczema
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Key takeaways:
- Anzupgo (delgocitinib cream, LEO Pharma) is an investigational topical pan-Janus kinase inhibitor.
- The committee’s positive opinion will be considered in the authorization process.
The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended the approval of Anzupgo for the treatment of chronic hand eczema in adults, LEO Pharma announced in a press release.
The Committee’s positive opinion for the approval of Anzupgo (delgocitinib cream, LEO Pharma), an investigational topical pan-Janus kinase inhibitor, is for adult patients with moderate to severe chronic hand eczema (CHE) that is inadequately controlled by topical corticosteroids.
“It is well known that CHE is challenging to live with and manage, potentially impacting personal relationships and careers,” Christophe Bourdon, MBA, CEO of LEO Pharma, said in the release. “Despite the considerable burden of the condition, treatments options approved for CHE have been limited. As an organization, we are dedicated to helping advance the standard of care for the benefit of people with skin conditions, and today we are one step closer to addressing the unmet need that may be faced by those living with CHE.”
The positive opinion is supported by data from the phase 3 DELTA program, which includes the 16-week DELTA 1 and DELTA 2 trials as well as the 36-week DELTA 3 open-label extension trial.
The European Commission will consider the committee’s positive opinion as it makes its final decision on the authorization of Anzupgo in the European Union.