The National Institute for Health and Care Excellence (NICE) of the UK has issued positive guidance for Janssen Pharmaceutical’s Tremfya (guselkumab) to treat adults suffering from moderate to severe plaque psoriasis.
This positive Health Technology Assessment will provide patients with access to the drug through the National Health Service (NHS) in England and Wales.
Guselkumab is a subcutaneously injectable biologic that selectively targets the interleukin (IL)-23 protein known to trigger an immune inflammatory response in psoriasis. The drug can be used for effective and sustained control of the condition.
As well as NICE’s decision, guselkumab has also secured positive opinion from Germany’s Federal Joint Committee (G-BA), which said that the drug comparatively demonstrated substantial additional therapeutic benefits.
Europe, the Middle East and Africa Janssen Immunology medical lead Jaime Oliver said: “The swift decision by two of Europe’s key Health Technology Assessment bodies reflects the positive results demonstrated in clinical studies of guselkumab for the treatment of moderate to severe plaque psoriasis.
“We are therefore working hard to ensure that eligible patients in Europe can access guselkumab as quickly as possible.”
Both positive opinions for guselkumab are based on findings from Phase III clinical studies, including the VOYAGE 1 and 2 trials which evaluated guselkumab in comparison with placebo and Humira (adalimumab) in a total of 837 and 992 subjects, respectively.
Data revealed consistent rates of skin clearance in patients treated with guselkumab for up to two years.
The drug gained European Commission’s marketing authorisation in November last year, and is currently undergoing further investigations in various countries in the European Union.