Apremilast Efficacy Results Disappoint But May Be Enough For Commercial Success
This article was originally published in Pharmaceutical Approvals Monthly
Celgene’s PDE-4 inhibitor met the primary endpoint in the first of two pivotal psoriasis trials, but analysts worried that the treatment effect was less than that seen in a Phase II study. Some analysts see a niche for apremilast in treatment-naïve patients before they move on to biologic therapy. Celgene aims to begin apremilast regulatory filings this autumn, first targeting psoriatic arthritis.
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Celgene reported strong sales for key products, led by Revlimid, during its year-end 2012 call. The biopharma affirmed 2013 guidance, detailing the key regulatory and commercial drivers that will power the global expansion of its hematology, oncology, and immunology franchises. In particular, it highlighted the commercial potential for apremilast.