Celgene's oral Otezla approved by EC for psoriasis and psoriatic arthritis
US biotech firm Celgene’s (Nasdaq: CELG) European subsidiary has received marketing authorization from the European Commission (EC) for Otezla (apremilast), the company’s oral selective inhibitor of phosphodiesterase 4 (PDE4), in two therapeutic indications. Celgene’s shares rose 3% to $121.81 on the news.
The two indications for Otezla approved are:
- for the treatment of moderate-to-severe chronic plaque psoriasis in adult patients who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen and ultraviolet-A light (PUVA); and
- alone or in combination with disease modifying antirheumatic drugs (DMARDs), for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior DMARD therapy.
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