FDA approves secukinumab for moderate-to-severe plaque psoriasis

January 23, 2015

FDA has approved secukinumab (Cosentyx, Novartis) for the treatment of moderate-to-severe plaque psoriasis.

FDA has approved secukinumab (Cosentyx, Novartis) for the treatment of moderate-to-severe plaque psoriasis. 

Psoriasis is an autoimmune skin condition that causes skin redness and irritation, and develops due to a combination of genetic and environmental factors. Plaque psoriasis is the most common type of psoriasis and is characterized by raised, red patches covered with a silvery white buildup of dead skin cells, or scales. These patches most often appear on the scalp, knees, elbows and lower back and are usually itchy and painful.

Cosentyx is a human monoclonal antibody that selectively binds to interleukin-17A (IL-17A), a protein which is involved in inflammation. Binding prevents the protein from binding its receptor, thus inhibiting its ability to trigger the inflammatory response involved in the development of plaque psoriasis.

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Cosentyx is administered as a monthly subcutaneous injection and is approved for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy, phototherapy, or both.

The safety and efficacy of Cosentyx was established in 4 different phase 3I clinical trials with more than 2,400 eligible participants with plaque psoriasis. Patients were randomized to receive either Cosentyx or a placebo, and the results showed a greater clinical response, with skin clear or almost clear, with Cosentyx than placebo.

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"The results seen from these clinical trials are increasing the efficacy bar compared with the data seen with previous psoriasis medications," said Mark Lebwohl, MD, of the department of dermatology at the Icahn School of Medicine at Mount Sinai in New York.

The most common side effects reported during clinical trials included nasopharyngitis, diarrhea, and upper respiratory tract infection. Cosentyx is approved with a Medication Guide advising patients that the drug affects the immune system and therefore they may be at an increased risk for infections.

Erin Bastick is a PharmD Candidate 2016, Ohio Northern University, Ada, Ohio, and an inpatient intern at University Hospitals, Cleveland.