Psoriasis is a baffling and stubborn skin disorder which is primarily caused by skin cells multiplying 10x times more than they should be. Plaque Psoriasis is in particular an inherited form and is the most common.
Leo Pharma’s drug Brodalumab aims at inhibiting the activity of a receptor, IL-17 cytokine to treat Plaque Psoriasis. The potential blockbuster drug was linked to suicidal tendencies after consumption when it first arrived at the market, causing its actual developer, AstraZeneca to sell its commercialization rights.
In the US, Valeant Pharmaceuticals took over and also managed a thumps up from the FDA, albeit not without a black box safety warning on suicidal ideation.
Leo Pharma owns the rights to the antibody drug in the EU and was just issued a positive opinion from the European Committee for Medicinal Products for Human Use (CHMP), authorizing its marketing; although the Pharma still has to strictly adhere to a follow-up procedure.
This verdict/conclusion was arrived upon due to the positive opinion generated during the three Phase III trials which without further confusion revealed that the drug was able to clean up neat and nice, the lesions caused by the psoriasis in a majority of patients. The results also surpassed Janssen’s psoriasis drug Ustekinumab, which aims to block the IL-12 and IL-23 cytokines.
Meanwhile, companies Novartis and Eli Lilly already have a similar drug- IL-17 antibody approved for treatment in the EU and the US; therefore, even though Brodalumab could outrun Ustekinumab, there is no running this drug especially with the black box warning affixed.