Brodalumab, a novel biologic treatment for adult patients with moderate to severe plaque psoriasis, has been granted a positive opinion from the European Committee for Medicinal Products for Human Use (CHMP), LEO Pharma has said.
Brodalumab is the only fully human monoclonal antibody that selectively targets the IL-17 receptor subunit A. By binding to the receptor with high affinity, brodalumab effectively blocks the biological activity of several pro-inflammatory IL-17 cytokines, which are important in psoriasis. Brodalumab is not currently licensed in the EU.
The positive opinion from the CHMP is supported by data from three clinical trials, AMAGINE-1 (n=661), AMAGINE-2 (n=1831) and AMAGINE-3 (n=1881), with a total of 4,373 patients with moderate to severe psoriasis; the largest study population of any new biologic treatment in psoriasis to date. All three studies evaluated the efficacy and safety of different doses of brodalumab compared to placebo. AMAGINE-2 and AMAGINE-3 also compared brodalumab to ustekinumab.
Results showed brodalumab offered many patients complete skin clearance (PASI 100) at 12 weeks compared to patients treated with ustekinumab.
In AMAGINE-1 83% of patients on brodalumab 210mg achieved PASI 75 compared to 3% of patients treated with placebo at 12 weeks, and 76% of patients achieved sPGA success versus 1% of patients treated with placebo. High levels of skin clearance were sustained with continuous brodalumab treatment through week 52.
Professor Kristian Reich, Dermatologist and Principal Investigator of the AMAGINE Phase 3 clinical trials programme for brodalumab, Hamburg, Germany, said: “Brodalumab works by blocking the pro-inflammatory cascade that leads to psoriasis, resulting in normalisation of skin inflammation. In the brodalumab clinical trials, the majority of patients achieve clear or almost clear skin within 3 months of treatment as measured by the psoriasis area and severity index (PASI) 100 or 90. In real terms, this means that patients get to the point where their psoriasis no longer bothers them and this is the ultimate treatment goal.”
Kim Domela Kjøller, Executive Vice President of Global Research and Development at LEO Pharma, said: “It is critical that people with psoriasis have the necessary tools and support to help them get through life as unhindered by their condition as possible and don’t feel it controls their life. At LEO Pharma we are committed to improving the lives of people with skin conditions, and this positive opinion from the CHMP takes us one step closer to being able to do exactly that for the people who matter most to us. The evidence for brodalumab demonstrates real promise and we hope that we can provide not only a new treatment option, but also the opportunity to help people living with moderate-to-severe psoriasis to take control of their condition and improve their lives significantly.”
Data from the three large randomised, controlled AMAGINE clinical trials, found brodalumab to be well tolerated, with an acceptable safety profile. The most common adverse events were arthralgia (joint pain), nasopharyngitis (inflammation of the nose and pharynx), headache, and upper respiratory tract infection. Cases of suicidal ideation and behaviour, including completed suicide, were reported in the clinical trials programme. A causal association between treatment with brodalumab and increased risk of suicidal ideation and behaviour has not been established. Brodalumab will be supported by post-marketing pharmacovigilance activities to capture and follow up on any reports of safety events.
The CHMP’s recommendation will now be referred to the European Commission, which has the authority to approve medicines for use in all EU countries. This announcement follows the approval of brodalumab by the U.S. Food and Drug Administration for plaque psoriasis in February 2017; and the approval by the Japanese Pharmaceuticals and Medical Devices Agency for psoriasis vulgaris, psoriatic arthritis, pustular psoriasis and psoriatic erythroderma in 2016.