Celgene Corp again offers impressive late-stage data on apremilast, an oral drug for psoriatic arthritis - this time in previously-untreated patients.
The company presented data from the 52-week PALACE 4 Phase III study of apremilast tested in PsA patients who have not taken systemic or biologic disease modifying antirheumatic drugs (DMARDs). PALACE 4 is the first large, randomized, controlled study to examine the efficacy and safety of a novel agent exclusively in systemic or biologic DMARD-naïve psoriatic arthritis patients.
“In addition to maintaining its long-term safety and tolerability profile consistent with the previously reported data, apremilast monotherapy showed significant clinical benefit in systemic or biologic DMARD-naïve psoriatic arthritis patients,” said Alvin Wells, M.D., Ph.D., Director, Rheumatology and Immunotherapy Center, Franklin, WI, US. “These encouraging results suggest that apremilast may have the potential to be used alone and as a first-line therapy.”
The New Drug Application and the New Drug Submission, based on the combined data from PALACE 1, 2 and 3 for psoriatic arthritis, were submitted to health authorities in the U.S. and Canada in Q1 2013 and Q2 2013, respectively. An NDA to the U.S. Food and Drug Administration for psoriasis, in addition to a combined psoriatic arthritis/psoriasis Marketing Authorization Application (MAA) in Europe, are on-track for the fourth quarter of 2013.