CHMP Backs Secukinumab, Apremilast for Psoriasis

Megan Brooks


November 21, 2014

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for two drugs for psoriasis: secukinumab (Cosentyx, Novartis) and apremilast (Otezla, Celgene).

Secukinumab is a fully human monoclonal antibody that inhibits the proinflammatory cytokine interleukin 17A. It was recommended for treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. It is administered by subcutaneous injection. The recommended dose is 300 mg.

In clinical trials, secukinumab proved superior to placebo and against the comparator etanercept (Enbrel, Amgen) in improving symptoms of plaque psoriasis. Secukinumab was "efficacious in systemic treatment naive, biologic-naive, biologic/anti-tumour necrosis factor (TNF)-exposed and biologic/anti-TNF-failure patients," the CHMP notes.

The most frequently reported adverse drug reactions were upper respiratory tract infections (most frequently nasopharyngitis and rhinitis). Most of the reactions were mild or moderate in severity.

A US Food and Drug Administration advisory committee voted unanimously to recommend approval of secukinumab for moderate to severe plaque psoriasis in October.


The CHMP also recommended approval of apremilast film-coated tablets, alone or in combination with disease-modifying antirheumatic drugs (DMARDs), in adults with active psoriatic arthritis who have failed to respond adequately to prior DMARD therapy or who are intolerant to DMARDs.

The committee also recommended approval of apremilast for the treatment of moderate to severe chronic plaque psoriasis in adults who fail to respond to, who have a contraindication to, or who are intolerant to other systemic therapy, including cyclosporine, methotrexate, or psoralen and ultraviolet A light.

The oral selective phosphodiesterase 4 inhibitor was approved in the United States for plaque psoriasis and psoriatic arthritis in September.

On the basis of quality, safety, and efficacy data submitted for apremilast, the CHMP considers there to be a favorable benefit-to-risk balance for apremilast, the committee said.

The most common adverse effects seen in clinical trials with apremilast are gastrointestinal disorders including diarrhea and nausea, upper respiratory tract infections, headache, and tension headache.

Secukinumab and apremilast should be initiated by specialists experienced in the diagnosis and treatment of the indicated conditions, the CHMP said.

A pharmacovigilance plan for both agents will be implemented as part of the marketing authorization.

Detailed recommendations for the use of both drugs will be described in the summary of product characteristics, which will be published in the European public assessment report and made available after the marketing authorization has been granted by the European Commission.


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