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Amgen recently announced that it has submitted a supplementary new drug application (sNDA) for the oral anti-inflammatory drug Otezla (apremilast) to the U.
The sNDA is based on data from the Phase 3 ADVANCE trial.
The results showed that the study reached the primary endpoint: Compared with the placebo group, the Otezla treatment group had a statistically significant improvement in the sPGA response at week 16.
The detailed results from the ADVANCE study will be announced at an upcoming medical conference.
Psoriasis is a serious chronic inflammatory disease that can cause raised red scales on the skin, usually affecting the elbows, knees, or the outside of the scalp, but it can also appear anywhere.
Otezla (apremilast) is an oral selective phosphodiesterase 4 (PDE4) small molecule inhibitor that regulates the network of pro-inflammatory and anti-inflammatory mediators in cells.
At present, Otezla has been approved for 3 treatment indications: (1) treatment of adult patients with moderate to severe plaque psoriasis; (2) treatment of adult patients with active psoriatic arthritis; (3) treatment with Behcet Adult patients with disease-related oral ulcers.
Original source: Amgen Submits Supplemental New Drug application for Otezla? (apremilast) for Adults with Mild-To-Moderate Plaque Psoriasis
