FDA approves third indication for Otezla

20 July 2019

The US Food and Drug Administration (FDA) has approved Otezla (apremilast) 30mg twice daily (BID) for the treatment of adult patients with oral ulcers associated with Behçet’s disease, it was revealed late Friday.

Otezla, marketed by US biotech firm Celgene (Nasdaq: CELG), has been commercially available in the USA since 2014 for patients with plaque psoriasis and psoriatic arthritis.

Otezla, an oral, selective inhibitor of phosphodiesterase 4 (PDE4), is the first and only approved treatment option for oral ulcers associated with Behçet’s Disease, a rare, chronic, multisystem inflammatory disease that is difficult to treat.

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