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FDA Gives Nod to Psoriasis Treatment Secukinumab (Cosentyx)
The FDA has approved secukinumab (Cosentyx, Novartis) for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy, phototherapy, or a combination of both.
Secukinumab is the first approved psoriasis medication to selectively bind to interleukin-17A (IL-17A), thereby inhibiting interaction with the IL-17 receptor. The drug is administered via subcutaneous injection.
The FDA’s approval follows a unanimous vote by one of its advisory committees in October 2014.
The agency based its decision on data from 10 phase II and phase III trials, which examined the efficacy and safety of secukinumab (150 mg and 300 mg) in a total of 3,990 patients with moderate-to-severe plaque psoriasis. In these studies, safety and efficacy outcomes met all primary and key secondary endpoints, including the Psoriasis Area and Severity Index (PASI 75 and PASI 90) and the Investigator’s Global Assessment modified 2011 (IGA) 0/1 responses, showing significant skin clearance at week 12.
The PASI measures the redness, scaling, and thickness of psoriatic plaques, and the extent of involvement in each region of the body. Treatment efficacy is assessed by the reduction of the score from baseline (i.e., a 75% reduction is known as PASI 75, and a 90% reduction is known as PASI 90).
Secukinumab is an antibody that binds to the protein interleukin-17A (IL-17A), which is involved in inflammation. By binding to IL-17A, secukinumab prevents it from binding to the IL-17 receptor and inhibits its ability to trigger the inflammatory response that plays a role in the development of plaque psoriasis.
In addition to plaque psoriasis, secukinumab is being evaluated for the treatment of active psoriatic arthritis and ankylosing spondylitis.
Psoriasis affects an estimated 7.5 million Americans and more than 125 million people worldwide. Nearly 35% of psoriasis patients have moderate-to-severe disease.
Sources: FDA; January 21, 2015; and Novartis; January 21, 2015.