Amgen announced that the U.S. Food and Drug Administration (FDA) has approved Otezla (apremilast) for the treatment of adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy. With this expanded indication, Otezla is now the first and only oral treatment approved in adult patients with plaque psoriasis across all severities, including mild, moderate and severe.
“Plaque psoriasis can place a significant burden on the lives of patients, regardless of the severity of skin involvement. A substantial unmet need remains for mild to moderate plaque psoriasis patients for whom topical therapies may not be sufficient, especially for those with difficult-to-treat areas, like the scalp,” said David M. Reese, M.D., executive vice president of Research and Development at Amgen. “With this expanded indication for Otezla, patients across all levels of disease severity now have an oral, systemic option that has already been used by more than 650,000 people worldwide and has no lab monitoring requirement.”1
“Given that psoriasis is a systemic inflammatory disease, some patients may need more than surface level relief,” said Dr. Linda Stein Gold, director of Dermatology Clinical Research at Henry Ford Health System, Detroit, and ADVANCE investigator. “For the first time, dermatologists can offer patients struggling with plaque psoriasis of any degree an effective oral treatment with an established safety profile.”
The FDA approval is based on findings from the Phase 3 ADVANCE trial, in which five times as many adults with mild to moderate plaque psoriasis receiving oral Otezla 30 mg twice daily achieved the primary endpoint of Static Physician’s Global Assessment (sPGA) response at week 16 compared to placebo (21.6% versus 4.1%, p<0.0001), a difference that was statistically significant. Otezla also demonstrated statistically significant improvements in key symptoms, such as Whole Body Itch NRS response (43.2% versus 18.6%), and a difficult-to-treat area, the scalp, measured by Scalp Physician’s Global Assessment (ScPGA) response (44% versus 16.6%), at week 16 compared to placebo. Improvements in sPGA response, Whole Body Itch NRS and ScPGA response were observed as early as week 2 and maintained through week 32.
Approximately 8 million people in the U.S. have plaque psoriasis, and 5 million people in the U.S. have mild to moderate disease.