Celgene Receives EU OK for Psoriasis Drug
Celgene International SÃ rl, a wholly-owned subsidiary of Celgene Corporation, as been granted marketing authorization for the European Commission (EC) for Otezla (apremilast), the company’s oral selective inhibitor of phosphodiesterase 4 (PDE4), in two therapeutic indications for treating psoriasis.
The drug was approved 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). It was also approved for use 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.
Otezla was approved in March 2014 by the US Food and Drug Administration for the treatment of adults with active psoriatic arthritis and in September 2014 for the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. Marketing authorization applications are ongoing in other countries, including Australia and Switzerland.
Otezla is the first in a new class of medicines for the treatment of both psoriasis and psoriatic arthritis, two diseases involving dysregulated immune system activity. The drug will be launched in the European Union in the coming months in accordance with local requirements.