Novartis announces FDA Advisory Committee unanimously recommends approval of AIN457 (secukinumab) for patients with moderate-to-severe plaque psoriasis - Seite 2

The Phase III clinical program for secukinumab included four placebo-controlled pivotal studies which examined secukinumab 300 mg and 150 mg in patients with moderate-to-severe plaque psoriasis. In these studies, secukinumab met all primary and key secondary endpoints, including Psoriasis Area and Severity Index (PASI) 75 and 90 and Investigator's Global Assessment modified 2011 (IGA mod 2011) 0/1 responses, showing significant skin clearance at Week 12[5]-[7]. 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[7]. PASI measures the redness, scaling and thickness of psoriatic plaques, and the extent of involvement in each region of the body[8]. 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). PASI 90 is a higher standard of skin clearance compared to PASI 75[8].

Currently available data showed no major safety issues. In the pooled analysis of the placebo-controlled period of the pivotal Phase III studies, the incidence of serious adverse events (SAEs) was low and comparable for both doses of secukinumab and placebo (2.0% for both 300 mg and 150 mg vs. 1.7% for placebo)[5]-[7]. Commonly reported adverse events (AEs) observed with secukinumab were nasopharyngitis, headache, diarrhea, pruritus (itching), and upper respiratory infection[5]-[7].

Novartis submitted a Biologics License Application (BLA) for secukinumab to the FDA in October 2013 and the FDA action date is expected in early 2015. Additionally, submissions have been made with regulatory authorities in the EU with an expected decision anticipated in late 2014 or early 2015.

According to an analysis of surveys conducted of 5,600 patients by the National Psoriasis Foundation (NPF) between 2003 and 2011, 52% of patients with mild, moderate and severe psoriasis were dissatisfied with their disease management[2]. Of the patients surveyed, some were receiving no treatment (9.4-49.2%) or were undertreated (10.2-55.5%)[2].

About Psoriasis
Affecting 7.5 million Americans and more than 125 million people worldwide, psoriasis is a chronic immune-mediated disease characterized by thick and extensive skin lesions (plaques), which can cause itching, scaling, and pain[1],[9],[10]. Patients reported these symptoms can negatively impact their quality of life, both psychosocially and physically, which makes daily functioning difficult[1]-[3]. Additionally, patients with psoriasis are at increased risk for other chronic illnesses[3].