Amgen has submitted a supplemental new drug application (sNDA) seeking expanded approval for Otezla in adults with mild-to-moderate plaque psoriasis who are candidates for phototherapy or systemic therapy.
The submission to the US Food and Drug Administration (FDA) is based on data from the Phase III ADVANCE trial.
In this trial, Otezla (apremilast) 30mg twice daily achieved a statistically significant improvement in the primary endpoint of the static Physician’s Global Assessment (sPGA) response compared to placebo, at week 16.
In addition, Otezla demonstrated statistically significant improvements in key secondary endpoints compared to placebo.
This includes achieving at least a 75% improvement from baseline in affected body surface area (BSA), change in BSA total score from baseline and change in Psoriasis Area and Severity Index (PASI) total score from baseline at week 16.
“Despite treatment advances, there remains an unmet need for people with clinically mild-to-moderate plaque psoriasis who use existing topical therapies and still have challenges managing their disease, particularly those with disease in hard-to-treat locations,” said David Reese, executive vice president of research and development at Amgen.
“Results from the ADVANCE trial demonstrated the potential of Otezla to provide an oral, non-biologic option for these patients,” he added.
Otezla is already approved in the US for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy, adult patients with active psoriatic arthritis and for adults patients with oral ulcers associated with Behçet’s Disease.