Novartis AG's Secukinumab Has Consistent Activity In Psoriasis

October 13, 2014

By Jessica Wilson, BioSpace.com Breaking News Staff

Novartis AG , the Basel, Switzerland-based pharmaceutical company, announced on Friday new analyses of Phase III studies of secukinumab, the company’s drug for the treatment of moderate-to-severe plaque psoriasis. The studies show that treatment with secukinumab, a fully human monoclonal antibody, resulted “in higher rates of clear to almost clear skin at Week 12 versus placebo, regardless of patients’ psoriasis disease severity,” according to a press release issued by Novartis.

The data was presented on Friday at the European Association of Dermatology and Venereology (EADV) Congress, in Amsterdam, Netherlands.

Regulatory reviews for secukinumab are underway. An advisory committee meeting of the U.S. Food and Drug Administration (FDA) is scheduled for Oct. 20 of this year. In addition, a recommendation by the Committee for Medicinal Products for Human Use (CHMP), the committee at the European Medicines Agency (EMA) responsible for issuing opinions on questions concerning medicines for human use, is expected in the fourth quarter of 2014.

“We are excited to continue seeing new positive results for secukinumab in psoriasis, this time showing consistent high rates of skin clearance regardless of disease severity as well as the positive relationship clearing skin has on patients’ quality of life,” said Vasant Narasimhan, global head of development at Novartis. “With global regulatory approvals anticipated shortly, we hope to bring secukinumab to patients living with this debilitating disease, which impacts much more than their skin.”

Novartis currently has data from four Phase III studies of secukinumab in patients with moderate-to-severe plaque psoriasis. The studies were multicenter, randomized, double-blind and placebo-controlled. The analyses presented at the EADV Congress involved data pooled from two of the four studies.

The data from those two studies indicates that patients with psoriasis, which varied in severity, experienced clear to almost clear skin, measured by the reduction of redness, scaling and thickness of psoriatic plaques as well as by the reduction in the area of the body covered by psoriatic plaques. Patients—even ones with severe psoriasis—experienced skin clear of psoriatic plaques through the entire year of treatment. According to Novartis, “This is important as historically, psoriasis patients’ disease severity at the start of treatment has been shown to negatively impact their response to other therapies.”

Secukinumab stops a protein called interleukin-17A (IL-17A), which is found in high concentrations of skin affected by psorias, from its involvement in the development of the disease. Phase III studies of secukinumab selectively targeting IL-17A for the treatment of psoriasis have been the first of their kind to be published.

Phase III results of the drug were first presented in October 2013; Phase IIIb trials are ongoing.