FDA approves Otezla for patients with plaque psoriasis of all severities

The FDA has approved Otezla for the treatment of patients with plaque psoriasis of all severity levels, according to a company press release.

The approval makes Otezla (apremilast, Amgen) the first oral therapy for patients with all severities of plaque psoriasis.

"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," David M. Reese, MD, executive vice president of and at Amgen, said in the release.

The approval follows the ADVANCE phase 3 trial. In the trial, five times as many adults with mildtomoderate plaque psoriasis who received Otezla 30mg twice per week achieved the primary endpoint, Static Physician's Global Assessment response at week 16 compared with patients who received placebo (P < .0001).

The most common treatment-emergent adverse events reported 5% patients included diarrhea, headache, nausea and nasopharyngitis, according to the release.

Otezla is now FDA-approved for three indications, 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