EU approves LEO Pharma’s psoriasis biologic

A new treatment option has been approved in the European Union for patients with psoriasis, paving the way for access to a novel approach for those with moderate-to-severe forms of the disease who are candidates for systemic therapy.

LEO Pharma’s Kyntheum (brodalumab) is a novel biologic and the first and only psoriasis treatment to target the L-17 receptor.

By binding to this specific receptor on the cells of the skin, brodalumab blocks the biological activity of several pro-inflammatory IL-17 cytokines involved in plaque formation, offering a different mechanism of action to all other psoriasis biologics currently available, which target free inflammatory mediators.

In the clinical trials, 37-44 percent of patients treated with the drug achieved complete skin clearance (PASI 100) at week 12, compared with 19-22 percent with ustekinumab, with "high levels" of skin clearance sustained with continuous brodalumab treatment through week 52.

The most common adverse events linked to the drug were arthralgia (joint pain), nasopharyngitis (inflammation of the nose and pharynx), headache, and upper respiratory tract infection, LEO noted.

Kyntheum’s approval is "an important milestone for nearly two million people living with psoriasis in the UK, a quarter of whom will have, or may develop, a moderate or severe form of the disease," said Professor Richard Warren, consultant dermatologist, North West, Salford Royal NHS Foundation Trust.

"Despite recent advances in treatment, there are still some patients who cannot achieve the complete, sustained skin clearance they desire. Brodalumab with its differentiated mode of action represents a valuable treatment option, one I believe will be welcomed in the field of dermatology."

EU clearance follows that in US where the drug was approved under the brand name Siliq, but with a boxed warning on suicide and a restricted prescriber programme. Valeant holds US rights to the drug.

Nearly 1.8 million people live with psoriasis in the UK, and 25 percent of them can develop a moderate or severe form of the disease.