EU approval for Otezla (apremilast) for Psoriasis and Psoriatic Arthritis- Celgene

Celgene International Sàrl a wholly-owned subsidiary of Celgene Corporation has announced that the European Commission (EC) has granted marketing authorisation for Otezla (apremilast), the company's oral selective inhibitor of phosphodiesterase 4 (PDE4), in two therapeutic indications:1 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). 2.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, a selective PDE4 inhibitor, 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.

Comment: Otezla delivered twice a day, is the first oral drug for Psoriasis and PsA for many years. It will offer greater convenience than the injectable TNF alpha antagonists. It is also distinguished from that class, such as Humira (adalimumab) and Enbrel (etancercept) and from Cimzia (certolizumab) as it does not carry a warning against serious infections and malignancies.

About half of Psoriasis and PsA patients in a survey published in the Journal of the American Academy of Dermatology who were undergoing traditional treatments or biologics found their treatments burdensome.