Novartis’ Cosentyx cleared for psoriasis in Europe

Novartis’ Cosentyx has become the first drug in the emerging interleukin-17 (IL-17) inhibitor class to be approved for psoriasis in Europe.

Cosentyx (secukinumab) has been approved by the European Commission as a first-line treatment for moderate-to-severe psoriasis, the first biologic therapy to be given a green light for front-line use in the EU.

All other biologic agents for psoriasis, including TNF blockers such as Amgen/Pfizer’s Enbrel (etanercept) and AbbVie’s Humira (adalaimumab) as well as Johnson & Johnson’s IL-12/23 inhibitor Stelara (ustekinumab), are reserved for second-line use in the EU.

Head of Novartis Pharmaceuticals David Epstein said: “Nearly half of psoriasis patients are not content with current therapies, including biologic treatments, showing a significant unmet need.”

Novartis’ drug was first approved in Japan at the end of December as a treatment for psoriasis and psoriatic arthritis in adults who fail to respond adequately to systemic therapies apart from biologics, and has also been registered in Australia for psoriasis.

Meanwhile it is also expected to be approved in the US in the coming weeks, after being recommended for approval by an FDA advisory committee last October.

In trials, Cosentyx was found to be superior to both Enbrel and Stelara in resolving the red, itchy skin lesions that characterise psoriasis, with 100% or 90% clearance on the psoriasis area and severity index (PASI 100 or 90 score) in 70% or more of treated patients within 16 months of starting treatment.

Novartis has a comfortable lead in the anti-IL-17 category over nearest competitors Amgen/AstraZeneca (AZ) – whose brodalumab candidate is due for filing later this year – as well as Eli Lilly which has ixekizumab in the final stages of clinical development.

The drug has been tipped for sales of $1bn-plus by 2020, with additional upside if follow up indications in psoriatic arthritis and ankylosing spondylitis – also scheduled for filing this year – are added to its label.

Novartis said it also has clinical trials of the drug ongoing in palmo-plantar psoriasis, nail psoriasis and palmo-plantar pustulosis.

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