FDA Approves Apremilast Tablets as a Generic for Psoriatic Arthritis

The US Food and Drug Administration (FDA) has approved apremilast (Otezla), commonly used to treat diseases such as psoriatic arthritis (PsA), Behcet’s Syndrome, and plaque psoriasis, as a generic drug in 10, 20, and 30 mg tablets.

The Drug

The approval for the oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) specific for cyclic adenosine monophosphate (cAMP) was awarded to Unichem Laboratories.

The therapy is currently approved in the US for the treatment of active PsA, moderate to severe plaque psoriasis in patients eligible for phototherapy or systemic therapy, and oral ulcers associated with Behcet’s Disease in adults.

Since it was initially approved in 2014, the treatment has been prescribed to more than 250,000 patients with moderate-to-severe plaque psoriasis or active psoriatic arthritis in the US.

ACR Data

Recently, during the American College of Rheumatology (ACR) Convergence 2020, investigators found the selective PDE4 inhibitor is associated with early and sustained benefit in patients regardless of their biologic treatment.

Investigators concluded apremilast was associated with slightly greater achievements in initiated and sustained clinical improvement among patients with psoriatic arthritis who have not taken prior biologics.

No Benefit for Ankylosing Spondylitis

However, the approval comes just days after new data showed apremilast did not yield patients with active ankylosing spondylitis (AS). In the phase 3, multicenter, double-blind, placebo-controlled study, the researchers randomized 490 patients with active AS to receive either apremilast 20 mg twice daily, apremilast 30 mg twice daily, or a placebo.

At Week 104, the mean changes from baseline in the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) were 0.83 (3.6), 0.98 (2.2), and 0.57 (1.9) in patients initially randomized to placebo, apremilast 20 mg, and apremilast 30 mg, respectively.