In Phase IIIb results announced Friday, Novartis said its psoriasis drug Cosentyx (secukinumab) demonstrated superiority against Johnson & Johnson's Stelara (ustekinumab) and met the primary endpoint of patients achieving a reduction in the Psoriasis Area Severity Index score of at least 90 percent (PASI 90) at week 16. "We are delighted that our IL-17A inhibitor Cosentyx," formerly known as AIN457, "showed superiority over Stelara, a widely-used biologic for moderate-to-severe psoriasis patients and a newer treatment alternative to TNF inhibitors," remarked Vasant Narasimhan, Novartis' global head of development.
The head-to-head CLEAR trial involved 679 patients with moderate-to-severe plaque psoriasis who were randomised to treatment with Cosentyx or Stelara for 52 weeks. In addition to the primary endpoint, Cosentyx also met its secondary goal of patients achieving PASI 75 responses at week four. Novartis also noted that "safety results were consistent" with previously reported Phase III Cosentyx trials and that data from the CLEAR study will be submitted for presentation at a medical conference next year.
In July 2013, Novartis released results from the late-stage FIXTURE study illustrating the superiority of Cosentyx to Amgen's Enbrel (etanercept) in clearing skin in patients with moderate-to-severe plaque psoriasis.
Last month, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending Cosentyx for use as a first-line systemic treatment of moderate-to-severe plaque psoriasis in adult candidates for systemic therapy. Meanwhile, an FDA advisory panel recently recommended approval of the therapy for the treatment of moderate-to-severe plaque psoriasis in adults deemed suitable for systemic therapy or phototherapy.
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