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FDA APPROVES OTEZLA® (APREMILAST) FOR THE TREATMENT OF ADULT PATIENTS WITH PLAQUE PSORIASIS, REGARDLESS OF SEVERITY LEVELMonday December 20, 2021 at 6:44 pm
THOUSAND OAKS, Calif., Dec. 20, 2021 /PRNewswire/ — Amgen (NASDAQ: AMGN) today 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.
The adverse events observed in the trial were consistent with the known safety profile of Otezla. The most commonly reported (≥5%) treatment-emergent adverse events with Otezla treatment were diarrhea, headache, nausea and nasopharyngitis.
Approximately 8 million people in the U.S. have plaque psoriasis, and 5 million people in the U.S. have mild to moderate disease. Despite the prevalence and treatment advances in recent years, a significant unmet need remains, particularly for people with mild to moderate plaque psoriasis or those who experience persistent symptoms despite topical treatment.
“Plaque psoriasis often affects patients more severely than can be measured by Body Surface Area alone, particularly for those with manifestations in difficult-to-treat areas like the scalp. The location of plaques may make the area sensitive to topical treatments or challenging to apply them,”2 said Stacie Bell, Ph.D., chief scientific and medical officer at the National Psoriasis Foundation. “It’s welcome news to finally have an oral systemic option with a well-established safety profile available for all adult plaque psoriasis patients.”
Otezla is approved for three indications in the U.S., including adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy, adult patients with active psoriatic arthritis and for adult patients with oral ulcers associated with Behçet’s Disease. Otezla is the most prescribed brand for plaque psoriasis patients starting systemic therapy.3 Amgen is committed to investigating the potential of Otezla across the continuum of psoriasis, including underserved patients with genital psoriasis, pediatric psoriasis, juvenile psoriatic arthritis and other areas of high burden.