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FDA committee unanimously recommends approval of AIN457 for psoriasis treatment
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Novartis has announced that the Dermatologic and Ophthalmic Drugs Advisory Committee to the U.S. Food and Drug Administration voted unanimously to support the approval of AIN457 for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy.
The committee based its recommendation on the outcomes from 10 psoriasis phase 2/3 clinical studies including nearly 4,000 patients with the condition, according to a company press release.
In the phase 3 clinical program, AIN457 (secukinumab) — a selective interleukin-17A inhibitor — met all primary and key secondary endpoints, including Psoriasis Area and Severity Index 75 and 90 and Investigator’s Global Assessment modified 2011 0/1 responses, which showed significant skin clearance at week 12. In addition, patients who continued with treatment maintained the response at week 52.
The researchers discovered no major safety issues, according to the press release.
Novartis submitted a Biologics License Application to the FDA for secukinumab in October 2013; the FDA action date is expected in early 2015.
Submissions to regulatory authorities have also been made in the E.U., with a decision anticipated in late 2014 or early 2015, according to the release.