FDA Approves New Psoriasis Drug

The US Food and Drug Administration (FDA) approved secukinumab (Cosentyx/Novartis) for adults with moderate to severe plaque psoriasis.

The European Commission approved the same drug on Jan. 19.

Its active ingredient is an antibody that binds to interleukin-17A and interferes with inflammation. The binding prevents that protein from triggering the inflammatory response that results in psoriasis patches.

It is delivered by subcutaneous injection. According to the FDA, “it is intended for patients who are candidates for systemic therapy, phototherapy, or a combination of both”.

The drug’s US clinical trials involved 2,403 plaque psoriasis patients. Those who got secukinumab had better clinical results than those who got a placebo, with “skin that was clear or almost clear,” the FDA reported.

According to Novartis, the European approval came after two trials showing that the drug worked better than ustekinab (Stelara/Jannsen) in the CLEAR study (the CLEAR study) and etanercept (Enbrel/Amgen) in the FIXTURE study.

The Novartis drug has also been approved in Australia and in Japan, both for treating adults who have moderate to severe plaque psoriasis. In Japn it is also approved for treating active psoriatic arthritis.