European committee gives positive opinion for brodalumab for psoriasis

The European Committee for Medicinal Products for Human Use has given a positive opinion to recommend marketing authorization for brodalumab for treating adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy, according to LEO Pharma.

Brodalumab, a fully human monoclonal antibody that selectively targets the IL-17 receptor subunit A, is not currently licensed in the European Union, LEO Pharma reported in a news release. The FDA approved brodalumab, marketed as Siliq by Valeant Pharmaceuticals in the United States, in February 2017 for treating psoriasis vulgaris, psoriatic arthritis, pustular psoriasis and psoriatic erythroderma.

The positive opinion of the Committee for Medicinal Products for Human Use (CHMP) was based off results of three clinical trials of 4,737 patients with moderate-to-severe psoriasis, which studied the efficacy and safety of different doses of brodalumab compared to placebo, and in two of the trials, also comparing brodalumab to Stelara (ustekinumab, Janssen).

Complete skin clearance (Psoriasis Area Severity Index [PASI] 100) at 12 weeks was achieved by 44% and 37% of patients treated with brodalumab compared with 22% and 19% of patients treated with ustekinumab in the two trials (P < .001, both). PASI 75 was achieved by 83% of patients treated with brodalumab 210 mg compared with 3% of patients treated with placebo in the other trial, according to the release.

Data from the three AMAGINE trials found brodalumab to have an acceptable safety profile with common adverse events including arthralgia, nasopharyngitis, headache, and upper respiratory tract infection.

Cases of suicidal ideation and behavior, including completed suicide, were reported in the clinical trials program, however, a causal association between treatment with brodalumab and increased risk of suicidal ideation and behavior was not established, according to the release. Post-marketing pharacovilgilience activities will be established for brodalumab, LEO Pharma reported.

CHMP's recommendation will now be referred to the European Commission, which has the authority to approve medicines for use in all EU countries.

LEO Pharma entered into a partnership agreement in July 2016 with AstraZeneca granting LEO exclusive license to develop and commercialize brodalumab in Europe. Valeant Pharmaceuticals has global commercial rights outside Europe except in Japan and certain other Asian countries, where the rights are held by Kyowa Hakko Kirin Co. Ltd., according to the release.

Reference: www.leo-pharma.com