EU CHMP recommends approval of Siliq (brodalumab) for patients with moderate-to-severe plaque psoriasis- LEO Pharma

LEO Pharma has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending the approval of Siliq (brodalumab) for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy.

The CHMP positive opinion is based on data from the three AMAGINE Phase III pivotal studies that demonstrated that brodalumab has an effective mechanism of action that delivers clinical benefit and could help a significant number of moderate-to-severe plaque psoriasis patients achieve total clearance of their skin disease. At the 210mg dose, brodalumab was shown to be efficacious in total skin clearance of psoriasis with approximately twice as many patients on brodalumab achieving total skin clearance compared to ustekinumab at week 12 in two replicate comparator trials involving over 2,400 patients.

Comment: this announcement follows the approval of brodalumab by the US Food and Drug Administration (FDA) (brand name Siliq) in February 2017 and the approval by the Japanese Pharmaceuticals and Medical Devices Agency, in 2016.