Amgen's Apremilast Tablets Nominated for Priority Review in China Following $13.4B Acquisition

On February 20, the CDE website indicated that Amgen’s marketing application for apremilast tablets was proposed for inclusion in the priority review program, for the treatment of psoriasis.

Apremilast is a small-molecule phosphodiesterase 4 (PDE-4) inhibitor that primarily exerts its therapeutic effects by modulating intracellular pro-inflammatory and anti-inflammatory cytokines. Apremilast was first approved in the United States in March 2014 for the treatment of active psoriatic arthritis in adults, and its indications were subsequently expanded to include moderate-to-severe plaque psoriasis and oral ulcers associated with Behçet’s syndrome.

Molecular Structural Formula of Apremilast

In November 2018, apremilast was included in the “First Batch of Clinically Urgent Overseas New Drugs” list by the Center for Drug Evaluation (CDE) on the grounds of its favorable efficacy and tolerability, oral route of administration, novel mechanism of action, and the absence of any drug with this mechanism currently marketed in China for the treatment of psoriasis.

According to the PharmaGo database by Medicine Cube, there are currently 9 companies in China conducting bioequivalence (BE) clinical studies on apremilast.

Apremilast was developed by Celgene, a subsidiary of Bristol Myers Squibb (BMS). In August 2019, Amgen acquired the global development rights to apremilast for $13.4 billion. According to Amgen’s recently released financial report, global sales of apremilast reached $2.195 billion in 2020.