FDA Approves Apremilast for Adult Patients with Plaque Psoriasis Across All Severities

The US Food and Drug Administration (FDA) has approved apremilast (Otezla) for the treatment of adults patients plaque psoriasis in adult patients who are candidates for phototherapy or systemic therapy.

Apremilast is an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) specific for cyclic adenosine monophosphate (cAMP). The drug is now the first and only treatment approved in adult patients with plaque psoriasis across all severities, including mild, moderate, and severe.

The approval is based on data from phase 3 of the ADVANCE trial, in which 5 times as many adult patients with mild-to-moderate plaque psoriasis who received apremilast 30 mg twice-daily achieved the primaty endpoint of Static Physician's Global Assessment (sPGA) response at week 16 compared to placebo (21.6% versus 4.1%, p<0.0001).

This difference was deemed statistically significant, and adverse events in the trial were consistent with the known safety profile of apremilast.

"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, PhD, chief scientific and medical officer at the National Psoriasis Foundation.

The therapy was previously approved in the US for the treatment of active psoriatic arthritis and moderate to severe plaque psoriasis in patients eligible for phototherapy or systemic therapy in addition to oral ulcers associated with Behcet’s Disease in adults.

The treatment has been prescribed to over 250,000 patients with moderate-to-severe plaque psoriasis or active psoriatic arthritis since its approval in 2014.

Further, a recent, 52-week study from Italy suggested that patients treated with apremilast were shown to have demonstrated a good response to treatment within the first few weeks of the study, at time improving their outcomes along the way.

Adverse events were deemed “transient and mostly self-limiting.”

"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, MD, executive vice president of Research and Development at Amgen, in a company statement.