- As expected, the European Commission approves Celgene's (NASDAQ:CELG +1.8%) Otezla (apremilast) for two indications:
- For the treatment of adult patients with moderate-to-severe plaque psoriasis who failed to respond to or who have a contraindication to or are intolerant of other systemic therapies, including cyclosporine, methotrexate or psoralen and ultraviolet-A light (PUVA).
- For the treatment, alone or in combination with Disease Modifying Antirheumatic Drugs (DMARDs), of adult patients with active psoriatic arthritis who have had an inadequate response to or are intolerant of a prior DMARD therapy.
- The European commercial launch will commence in the coming months. The FDA approved Otezla in March of last year.
- Previously: Europe Ad Comm recommends approval of Celgene's Otezla (Nov. 21, 2014)