Secukinumab moves toward approval for psoriasis treatment

An advisory committee for the Food and Drug Administration has voted to support approval of AIN457 (secukinumab, Novartis) for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.

The FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) based its recommendation on the outcomes of 10 clinical studies involving nearly 4,000 patients with moderate-to-severe plaque psoriasis.

The clinical trial program included four placebo-controlled studies that examined secukinumab in patients with moderate-to-severe plaque psoriasis, according to a news release. Secukinumab met all primary and key secondary endpoints in these studies, including Psoriasis Area and Severity Index (PASI) scores of 75 and 90, and Investigator’s Global Assessment modified 2011 (IGA mod 2011) 0/1 responses showing significant skin clearance at week 12. In addition, a majority of secukinumab-treated patients who achieved PASI 75 response and IGA mod 2011 0/1 at week 12 maintained the response at week 52 with continued treatment.

Study investigator Mark Lebwohl, M.D., chairman of the department of dermatology at Mount Sinai School of Medicine in New York, tells Dermatology Times, “Secukinumab is very effective, works quickly and provides a durable response, with many of the patients achieving complete clearance.”

The data showed no major safety issues. Researchers recorded a significantly low incidence of serious adverse events among the secukinumab and placebo patients: 2 percent for secukinumab and 1.7 percent for placebo. Commonly reported adverse events were nasopharyngitis, headache, diarrhea, pruritus and upper respiratory infection.

Novartis officials submitted a Biologics License Application (BLA) for secukinumab to the FDA a year ago and expect an action date the agency to take action on it in early 2015. They also have filed submissions with EU regulatory authorities and expect action on them later this year or in early 2015.

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