Leo picks up marketing nod for psoriasis biologic in EU

European approval for Pfizer’s psoriatic arthritis combo
Credit: Shutterstock.com/ Hriana

The European Commission has granted marketing authorisation to Leo Pharma’s new psoriasis biologic.

Kyntheum is intended for the treatment of moderate-to-severe plaque psoriasis in adults within the EU who are candidates for systemic therapy.

It is the first and only biologic that selectively targets the IL-17 receptor subunit A.

Psoriasis is a common, chronic, immune-mediated, inflammatory disease affecting an estimated 125 million people worldwide, including nearly 14 million Europeans.

Kyntheum is different from existing therapies. By specifically binding to the receptor on skin cells rather than targeting free floating inflammatory mediators, brodalumab blocks the biological activity of several pro-inflammatory IL-17 cytokines involved in psoriasis plaque formation.

“Results from the AMAGINE trials show that Kyntheum has the potential to virtually clear psoriasis in almost 80% of patients, often within just three months, establishing its approval as a major advancement within the field of psoriasis,” said Dr Ulrich Mrowietz, Psoriasis Centre, University Medical Centre, Schleswig-Holstein, Germany.

Kyntheum was well tolerated in all AMAGINE trials with an acceptable safety profile. Although cases of suicidal ideation and behaviour were reported, no causal association between treatment with Kyntheum and increased risk of suicidal ideation and behaviour has been established.

Its launch in Europe will be supported by post-marketing pharmacovigilance activities to capture and follow up on any reports of safety events.

Brodalumab is currently approved in the US and Japan for adult patients with moderate-to-severe plaque psoriasis.

In Japan, it is also approved for psoriasis vulgaris, psoriatic arthritis, pustular psoriasis and psoriatic erythroderma.