FDA Approves Amgen’s Otezla as First Oral Therapy for Adult Plaque Psoriasis Patients Across All Disease Severities

News on December 21, 2021 /BioValleyBIOON/ -- Amgen recently announced that the U.S. Food and Drug Administration (FDA) has been approvedOral anti-inflammatory drug Otezla (apremilast): For the treatment of adult patients with mild to moderate plaque psoriasis who are candidates for phototherapy or systemic therapy.In the United States, Otezla has previously been approved for the treatment of adult patients with moderate to severe plaque psoriasis.

It is worth mentioning that,Otezla is the first and only oral therapy approved for adult patients with plaque psoriasis across all disease severities, including mild, moderate, and severe.Now, Otezla is available for the treatment of all adult patients with plaque psoriasis, regardless of the severity of their condition.

Moreover, Otezla is the first and only oral therapy approved for adult patients with mild to moderate plaque psoriasis. In the United States, approximately 8 million people suffer from plaque psoriasis, with 5 million having mild to moderate disease. Despite the availability of topical treatments, many patients with mild to moderate plaque psoriasis still face significant challenges in controlling their symptoms, severely impacting daily life. Data from the Phase 3 ADVANCE trial shows:In patients with mild to moderate plaque psoriasis, Otezla significantly improved disease severity compared to placebo, regardless of the body surface area (BSA) affected by the disease.

Otezla is an oral anti-inflammatory drug developed by Celgene. In August 2019, it was acquired by Amgen for $13.4 billion. In January 2019, Bristol-Myers Squibb (BMS) acquired Celgene for $74 billion. However, as part of the antitrust review by the U.S. Federal Trade Commission (FTC), Otezla was required to be divested and was subsequently taken over by Amgen.

Otezla is an oral, selective phosphodiesterase 4 (PDE4) small molecule inhibitor., which has been approved for three indications (moderate to severe plaque psoriasis, active psoriatic arthritis, and Behçet's disease-related oral ulcers). At the time of acquisition, Otezla was the only oral, non-biologic therapy for treating psoriasis and psoriatic arthritis, and the only treatment for Behçet's disease-related oral ulcers. According to Amgen's 2020 earnings report, Otezla’s sales reached $2.195 billion, making it Amgen's third best-selling drug.

"Plaque psoriasis can significantly burden patients' lives, regardless of the severity of skin involvement," said David M. Reese, M.D., Executive Vice President of Research and Development at Amgen. "For patients with mild-to-moderate plaque psoriasis where topical treatments may be insufficient, especially for difficult-to-treat areas like the scalp, there remains a significant unmet need. With the expanded indication for Otezla, patients across all disease severities now have an oral, systemic treatment option. This medication has been used by more than 650,000 people worldwide and does not require laboratory monitoring."

Dr. Stacie Bell, Chief Scientific and Medical Officer of the National Psoriasis Foundation in the United States, stated: "The impact of plaque psoriasis on patients is often more severe than what can be measured by body surface area alone, especially for those who experience symptoms in difficult-to-treat areas such as the scalp. The location of the plaques may make the area sensitive to topical treatments or difficult to treat. This approval is exciting news, and we now finally have a safe and effective oral treatment option available for all adult patients with plaque psoriasis."

ADVANCE (PSOR-022, NCT03721172) is a multicenter, randomized, placebo-controlled, double-blind Phase 3 study evaluating the efficacy and safety of Otezla in treating mild to moderate plaque psoriasis. Mild to moderate plaque psoriasis is defined as: body surface area (BSA) involvement of 2%-15%, Psoriasis Area and Severity Index (PASI) score of 2-15, and static Physician Global Assessment (sPGA) score of 2-3. In this study, 595 patients were randomly divided into two groups in a 1:1 ratio, with one group receiving Otezla 30mg orally twice daily (n=297) and the other receiving placebo (n=298) for 16 weeks. After completing the 16-week treatment, all patients received Otezla treatment during the open-label extension period until Week 32. The primary endpoint was the percentage of patients achieving an sPGA response at Week 16. An sPGA response was defined as an sPGA score showing clear skin (0) or almost clear (1), with at least a 2-point improvement from baseline.

The results showed that the study met the primary endpoint:At Week 16 of treatment, a significantly higher proportion of patients in the Otezla group achieved sPGA 0/1 response compared to the placebo group (21.6% vs 4.1%, p＜0.0001).. These clinical improvements continued until the 32nd week. Additionally, at the 16th week of treatment,Compared with the placebo group, the Otezla treatment group showed statistically significant improvement in all secondary endpoints., including: a higher proportion of patients with BSA≤5% achieving BSA≤3% (71.7% vs 35.8%), BSA improving by at least 75% (29.0% vs 6.1%), and Scalp PGA (ScPGA) response scores indicating complete or almost complete clearance of lesions (ScPGA 0/1: 35.6% vs 12.9%). Consistent improvement in disease severity was also observed in adult patients with BSA＞5%. By Week 16 of treatment, compared to the placebo group, a higher proportion of patients with BSA＞5% in the Otezla treatment group achieved BSA≤3% (54.6% vs 14.9%), BSA improved by at least 75% (36.8% vs 8.6%), and ScPGA response scores of 0/1 (50.6% vs 19.2%).

In the trial, the observed adverse events were consistent with the known safety profile of Otezla. The most commonly reported (≥5%) treatment-emergent adverse events (TEAEs) in the Otezla treatment group were diarrhea (14.3%), headache (12.9%), nausea (12.7%), upper respiratory tract infection (8.5%), and nasopharyngitis (6.8%).

Psoriasis is a serious chronic inflammatory disease that causes raised, red, scaly patches to appear on the skin, typically affecting the outer sides of elbows, knees, or the scalp, but can occur anywhere. Approximately 125 million people worldwide suffer from psoriasis, including around 14 million in Europe and over 7.5 million in the United States. About 80% of these patients have plaque psoriasis.

Otezla (apremilast) is an oral, selective small molecule inhibitor of phosphodiesterase 4 (PDE4) that regulates a network of pro-inflammatory and anti-inflammatory mediators within cells. PDE4 is a cyclic adenosine monophosphate (cAMP)-specific PDE and is the predominant PDE in inflammatory cells. Inhibition of PDE4 leads to increased intracellular cAMP levels, which is believed to indirectly modulate the production of inflammatory mediators. The specific mechanism by which Otezla exerts its therapeutic effects in patients is not fully understood.

Currently, Otezla has been approved for three therapeutic indications: (1) the treatment of adult patients with mild, moderate, or severe plaque psoriasis; (2) the treatment of adult patients with active psoriatic arthritis; (3) the treatment of adult patients with oral ulcers associated with Behçet's disease. Since its first approval in the United States in 2014,FDASince its approval for marketing, more than 250,000 patients in the United States with moderate to severe plaque psoriasis or active psoriatic arthritis have received Otezla treatment. (Bioon.com)

Source of the original text:FDA APPROVES OTEZLA® (APREMILAST) FOR THE TREATMENT OF ADULT PATIENTS WITH PLAQUE PSORIASIS, REGARDLESS OF SEVERITY LEVEL