Leo Pharma has announced that its new psoriasis therapy Kyntheum has been approved by the European Commission.
The regulator has granted marketing authorisation for the new biologic, which is indicated as a treatment for moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
“Leo Pharma has received European regulatory approval for Kyntheum, a new biologic therapy for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.“
Kyntheum is the first and only biologic that selectively targets the IL-17 receptor subunit A rather than targeting free-floating inflammatory mediators, meaning it is able to block the biological activity of several proinflammatory IL-17 cytokines involved in psoriasis plaque formation.
The approval was supported by data from the AMAGINE clinical trial programme, which demonstrated the safety and efficacy of different doses of Kyntheum among 4,373 patients with moderate to severe psoriasis.
This represented the largest study population in the development programme of any new biologic treatment in psoriasis to date.
Gitte Pugholm Aabo, president and chief executive officer of Leo Pharma, said: "We hope that the EU approval of Kyntheum will help many more people to regain control, and live lives unrestricted by psoriasis, while our role is to support them throughout their journey to clear skin."
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