Otezla is the First and Only Oral Therapy Approved in Adult Patients with Plaque Psoriasis Across all Severities, Including Mild, Moderate and Severe

Approximately 8 Million People in the U.S. Have Plaque Psoriasis

THOUSAND OAKS, CA, USA I December 20, 2021 I 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.

About ADVANCE (PSOR-022)
ADVANCE (NCT03721172) is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study evaluating the efficacy and safety of Otezla in patients with mild to moderate plaque psoriasis (defined as BSA involvement of 2% to 15%, Psoriasis Area and Severity Index [PASI] score of 2 to 15, Physician’s Global Assessment [sPGA] score of 2 to 3). The study randomized 595 patients 1:1 to receive Otezla (n=297) 30 mg twice daily or placebo (n=298) for the first 16 weeks. All patients then received Otezla during an open-label extension phase through week 32.

The primary endpoint was the percentage of patients with sPGA response (defined as a sPGA score of clear [0] or almost clear [1] with at least a 2-point reduction from baseline) at week 16. Secondary endpoints include the percentage of patients with Whole Body Itch Numeric Rating Scale (NRS) score response (defined as at least a 4-point reduction from baseline, where 0 represents no itch and 10 represents the worst imaginable itch) and Scalp Physician Global Assessment (ScPGA) response (defined as an ScPGA score of clear [0] or almost clear [1] with at least a 2-point reduction from baseline) at week 16.

About Psoriasis
Psoriasis is a serious, chronic inflammatory disease that causes raised, red, scaly patches to appear on the skin, typically affecting the outside of the elbows, knees or scalp, though it can appear on any location. Approximately 125 million people worldwide have psoriasis, including around 14 million people in Europe and more than 8 million people in the United States. About 80% of those patients have plaque psoriasis.

About Otezla® (apremilast)
OTEZLA® (apremilast) is an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) specific for cyclic adenosine monophosphate (cAMP). PDE4 inhibition results in increased intracellular cAMP levels, which is thought to indirectly modulate the production of inflammatory mediators. The specific mechanism(s) by which Otezla exerts its therapeutic action in patients is not well defined.

Otezla® (apremilast) is indicated for the treatment of adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy.

Otezla is indicated for the treatment of adult patients with active psoriatic arthritis.

Otezla is indicated for the treatment of adult patients with oral ulcers associated with Behçet’s Disease.

Please click here for the full Prescribing Information for Otezla.

Amgen Inflammation
Amgen brings therapies to millions of people with inflammatory diseases, with a focus on serving unmet patient needs. For those with debilitating moderate-to-severe rheumatoid arthritis, psoriatic arthritis, moderate-to-severe plaque psoriasis, ankylosing spondylitis, asthma, and other chronic conditions, the suffering and needs are severe. Complex diseases of inflammation have defied simple solutions, and the breadth of inflammatory disease and the burden patients bear is not well understood.

For more than two decades, Amgen has been committed to advancing the science and the understanding around inflammation to address the unmet patient needs that exist and expanding our portfolio. We lead with science through discovery research that is disease-agnostic and biology-first, modality-second. In doing so, we have introduced and evolved novel therapies that have changed the lives of patients.

Our commitment to patients is reflected not only in where we have succeeded, but in where we have failed and opened new doors. Throughout, we have remained dedicated to the principle of leading with science, pursuing where pathways and promising discoveries in inflammation take us, and not relenting until innovative solutions for patients are found. It’s a commitment that extends beyond introducing novel therapies.

About Amgen
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be the world’s largest independent biotechnology company, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. 

Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average and is also part of the Nasdaq-100 index.  In 2021, Amgen was named one of the 25 World’s Best Workplaces™ by Fortune and Great Place to Work™ and one of the 100 most sustainable companies in the world by Barron’s.

For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.

1 Data on File at Amgen Inc.
2 Dopytalska, Klaudia et al. “Psoriasis in special localizations.” Reumatologia vol. 56,6 (2018): 392-398. doi:10.5114/reum.2018.80718
3 Data on File at Amgen Inc.