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22 Jan 2015

USFDA approved Novartis’s injectable drug, Cosentyx for plaque psoriasis

United States Food and Drug Administration had approved secukinumab to treat adults with moderate-to-severe plaque psoriasis.

  • Offering a new treatment option for patients, Cosentyx is the first approved human monoclonal antibody (mAb) that selectively binds to interleukin IL-17A
  • Phase III data demonstrated Cosentyx resulted in clear or almost clear skin in the majority of patients with moderate-to-severe plaque psoriasis
  • Approval based on the efficacy and safety outcomes from 10 Phase II and III studies which included over 3,990 adult patients with moderate-to-severe plaque psoriasis
  • Affecting 7.5 million Americans, psoriasis can negatively impact daily life and is associated with increased risk for other chronic illnesses

Secukinumab is a human monoclonal antibody designed for the treatments of uveitis, rheumatoid arthritis, ankylosing spondylitis, and psoriasis. It targets member A from the cytokine family of interleukin 17.

Psoriasis is a skin condition caused by dysfunction of the immune system. Patients with plaque psoriasis, the most common form of the disease, develop thick, red skin with flaky, silver-white patches called scales.

The active ingredient in Cosentyx, secukinumab, is part of an eagerly anticipated class of drugs that have shown unprecedented success in treating psoriasis by targeting the inflammation-causing protein interleukin-17 (IL-17).

Head-to-head clinical trial: Novartis’s secukinumab Vs. Johnson & Johnson’s Stelara Phase III trial

In a 679-patient study, Novartis’ secukinumab met its primary goal of reducing psoriasis symptoms by at least 90% at 16 weeks, the company said, demonstrating superiority to J&J’s treatment. The antibody also met its secondary endpoint of improving the signs of psoriasis by at least 75% after four weeks, according to Novartis.

In addition to the US, Cosentyx has been approved in the EU and Australia for the treatment of moderate-to-severe plaque psoriasis and in Japan for the treatment of moderate-to-severe plaque psoriasis and active psoriatic arthritis (PsA).

In addition to psoriasis, Cosentyx is also in clinical trials for the treatment of PsA and ankylosing spondylitis (AS). Global regulatory applications for secukinumab in AS and PsA are planned for 2015.

Ref: Press Release Novartis, January 21, 2015 18:31 CET.

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