Apremilast meets Phase III endpoint
Celgene Corp. (NASDAQ:CELG) said oral apremilast met the primary endpoint of improving the proportion of patients achieving an ACR20 response at week 16 vs. placebo in the Phase III PALACE-1 trial to treat psoriatic arthritis. The double-blind, international trial enrolled about 500 patients with active psoriatic arthritis who had received an oral DMARD, biologic therapy or had failed on an anti- tumor necrosis factor (TNF) agent.
PALACE-1 is the first of three Phase III trials of the oral phosphodiesterase-4 (PDE-4) inhibitor in psoriatic arthritis. Data from the PALACE 2 and 3 trials are expected this quarter. The product is also in the Phase III ESTEEM 1 and 2 trials to treat moderate to severe psoriasis, with data expected by year end. Celgene plans to submit an NDA to FDA for apremilast to treat psoriatic arthritis in 1H13, followed by an sNDA for psoriasis in 2H13. The company plans to submit a combined MAA to EMA for both indications in 2H13. ...