Psoriasis is a severe chronic inflammatory disease. In the United States, approximately 8 million people have plaque psoriasis, and 5 million have mild to moderate disease. Despite advances in the treatment of plaque psoriasis in recent years, significant unmet needs remain, particularly in patients with mild-to-moderate plaque psoriasis or those with persistent symptoms despite prior topical therapy.
On December 20, 2021, Amgen announced that the U.S. Food and Drug Administration (FDA) has approved Otezla (apremilast) for the treatment of adult patients with plaque psoriasis (suitable for phototherapy or systemic treatment). With the expanded indication, Otezla becomes the first and only oral medication approved for adult patients with plaque psoriasis of all severities, including mild, moderate and severe.
"Plaque psoriasis often affects patients more severely than measured by body surface area alone, especially those with manifestations in difficult-to-treat areas such as the scalp," said Stacie Bell, M.D., chief medical officer at the National Psoriasis Foundation. "The location of the plaques affects the sensitivity and ease of topical treatment. It is good to know that there is finally an oral medication option with a favorable safety profile that can be used by all adults with plaque psoriasis."
The FDA's approval was based on data from the Phase 3 ADVANCE trial, which showed that in adults with mild-to-moderate plaque psoriasis, five times more patients in the Otezla group (30 mg twice daily) met the primary endpoint of static physician global assessment (sPGA) response at week 16 than in the placebo group (21.6% vs. 4.1%), a difference that was statistically significant. Additionally, Otezla also demonstrated significant improvements compared to placebo at week 16 in key symptoms such as generalized pruritus NRS response (43.2% vs 18.6%) and difficult-to-treat scalp areas as measured by Scalp Physicians Global Assessment (ScPGA) response (44% vs 16.6%). Improvements in sPGA response, generalized pruritus NRS response, and ScPGA response were observed as early as week 2 and were maintained through week 32.
The adverse events observed in this trial were consistent with Otezla's known safety profile. The most common treatment-emergent adverse events (≥5%) were diarrhea, headache, nausea, and nasopharyngitis.
In the United States, Otezla has been approved for three indications, including adults with plaque psoriasis who are suitable for phototherapy or systemic treatment, adults with active psoriatic arthritis, and adults with oral ulcers associated with Behçet disease. Otezla is the most commonly prescribed brand for patients with plaque psoriasis when starting systemic treatment. Amgen is also working on Otezla's potential across the entire psoriasis continuum, including genital psoriasis, childhood psoriasis, juvenile psoriatic arthritis and others.
Reference materials: FDA instructions were updated on July 23, 2025. Instructions URL: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=205437
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