The overall safety profile was consistent with previous experiences in the phase II program. Importantly, no opportunistic infections (including TB) or lymphoma were observed through week 24, and there was no increase in risk of cardiovascular events. Apremilast was generally well tolerated. The majority of AEs (>95%) were mild or moderate, with serious AEs and discontinuations due to AEs similar across all treatment arms.An NDA submission to the U.S. Food and Drug Administration, based on the combined PALACE program for PsA, is expected in the first half of 2013. The sNDA submission for psoriasis is expected to follow in the second half of 2013. A combined MAA submission in Europe is also planned for the second half of 2013.
Oral Apremilast Achieves Statistical Significance For The Primary Endpoint Of ACR20 In The First Phase III Study (PALACE-1) In Patients With Psoriatic Arthritis
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