FDA Approves Apremilast (Otezla) for Plaque Psoriasis


September 23, 2014

The US Food and Drug Administration (FDA) has approved apremilast (Otezla, Celgene) for treating patients with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy, the manufacturer announced today.

The decision comes on the heels of the FDA's approval of apremilast in March to treat adults with active psoriatic arthritis. This type of arthritis occurs in 10% to 20% of patients with plaque psoriasis, which appears as raised red patches of skin covered with silvery white scales. It is the most common manifestation of psoriasis.

Apremilast is a selective inhibitor of phosphodiesterase 4, and the first and only one of its kind approved for treating plaque psoriasis, according to a Celgene news release.

Celgene stated that the FDA determined the efficacy and safety of apremilast mostly on the basis of 2 multicenter clinical trials — ESTEEM 1 and ESTEEM 2. Patients treated with the drug experienced significant, clinically meaningful improvement in plaque psoriasis at week 16 of the studies as measured by the Psoriasis Area and Severity Index. Patients also scored "clear" to "almost clear" on the static Physician's Global Assessment.

Diarrhea, nausea, upper respiratory tract infection, tension headache, and headache were among the adverse events observed in the studies. "Before starting Otezla, patients should inform their doctor if they have a history of depression or suicidal behavior and if these conditions or other mood changes develop or worsen while taking [the drug]," Celgene stated in its news release.

The drug has not been studied in pregnant women or in women who are breastfeeding. Accordingly, women should tell their clinician if they are pregnant, planning to become pregnant, or planning to breastfeed.


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