Apremilast is approved for all types of plaque psoriasis

0 36

The FDA has approved OTEZLA (APREMILAST) for the treatment of plaque psoriasis in adults, regardless of severity. Otezla is the First and Only Oral Treatment for Adults with Plaque Psoriasis in Mild, Moderate, and Severe Severities. In the United States, around 8 million people suffer from plaque psoriasis.

Amgen said on Monday that the FDA has authorised Otezla (apremilast) for the treatment of adult patients with plaque psoriasis who are not eligible for phototherapy or systemic therapy. Otezla is currently the first and only oral medication approved for adult patients with plaque psoriasis in all severities, including mild, moderate, and severe, thanks to this enlarged indication.

“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,” “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,”

said David M. Reese, M.D., executive vice president of Research and Development at Amgen. 

“Given that psoriasis is a systemic inflammatory disease, some patients may need more than surface level relief. For the first time, dermatologists can offer patients struggling with plaque psoriasis of any degree an effective oral treatment with an established safety profile.”

said Dr. Linda Stein Gold, director of Dermatology Clinical Research at Henry Ford Health System, Detroit, and ADVANCE investigator.

The FDA granted approval based on findings from the Phase 3 ADVANCE trial, which showed that 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 percent versus 4.1 percent, p0.0001). At week 16, Otezla showed statistically significant improvements in critical symptoms like Whole Body Itch NRS response (43.2 percent versus 18.6%) and a difficult-to-treat location, the scalp, as measured by Scalp Physician’s Global Assessment (ScPGA) reaction (44 percent versus 16.6%) compared to placebo. Improvements in sPGA response, Whole Body Itch NRS, and ScPGA response could be seen as early as week 2 and lasted until week 32.

The trial’s adverse events were consistent with Otezla’s well-known safety profile. Diarrhea, headache, nausea, and nasopharyngitis were the most commonly reported treatment-emergent side events with Otezla therapy (5%).

Plaque psoriasis affects about 8 million people in the United States, with another 5 million suffering from mild to moderate illness. Despite recent breakthroughs in psoriasis prevalence and treatment, there is still a considerable unmet demand, especially for persons with mild to moderate plaque psoriasis or those who have chronic 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. It’s welcome news to finally have an oral systemic option with a well-established safety profile available for all adult plaque psoriasis patients.”

said Stacie Bell, Ph.D., chief scientific and medical officer at the National Psoriasis Foundation.

In the United States, Otezla is approved for three indications: adult patients with plaque psoriasis who are eligible for phototherapy or systemic therapy, adult patients with active psoriatic arthritis, and adult patients with Behçet’s Disease oral ulcers. For plaque psoriasis patients initiating systemic medication, Otezla is the most commonly prescribed brand. 3 Amgen is committed to researching Otezla’s potential throughout the psoriasis spectrum, particularly underserved patients with genital psoriasis, paediatric psoriasis, juvenile psoriatic arthritis, and other high-burden areas.

Leave A Reply

Your email address will not be published.