Oral Otezla (apremilast) approved by the European Commission for the treatment of both patients with psoriasis and psoriatic arthritis

EMA

Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation, today 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:

  • 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)
  • 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

"The approval of Otezla is an important new option for the treatment of patients who are not experiencing adequate relief for their conditions. Otezla has shown significant and clinically meaningful improvements in psoriasis and psoriatic arthritis, including difficult to treat areas such as nail, scalp, and itch, which can all be the cause of great burden for patients," said Dr. Diamant Thaci, Professor of Dermatology and the Head of the Comprehensive Center of Inflammation and Medicine at the University of Lübeck, in Germany. "Otezla has also been generally well tolerated and does not require routine laboratory monitoring, which can be beneficial for both physicians and patients.

For more details, go to: http://ir.celgene.com/releasedetail.cfm?ReleaseID=891728

Michael Wonder

Posted by:

Michael Wonder

Posted in: