Celgene's oral phosphodiesterase 4 inhibitor Otezla (apremilast) received FDA approval for the treatment of moderate-to-severe plaque psoriasis in patients for whom phototherapy or systemic therapy is appropriate, the drugmaker reported Tuesday. Scott Smith, Celgene's president of inflammation & immunology, remarked "Otezla offers a valuable treatment option for a spectrum of plaque psoriasis patients - patients who are treatment-naïve as well as patients who are treatment-experienced, including those previously treated with biologic agents or conventional systemic agents."
The expanded approval of the therapy was based on data from three Phase III trials involving 1426 adult patients with moderate-to-severe plaque psoriasis. In the ESTEEM 1 and ESTEEM 2 studies, Otezla was associated with significant and clinically meaningful improvements in plaque psoriasis as indicated by Psoriasis Area and Severity Index scores at week 16 versus placebo, while clinical improvement as indicated by static Physician Global Assessment scores of clear or almost clear was noted in both trials.
Otezla received US clearance in March for the treatment of adults with active psoriatic arthritis, while the therapy was submitted for approval for the same indication in Canada in the second quarter of 2013. The drug was also submitted for approval in Canada for the treatment of psoriasis and for psoriasis and psoriatic arthritis in Europe in the fourth quarter last year. Analysts project sales of about $1 billion for the drug by 2017.
Celgene is also developing the therapy for a number of other indications. Earlier this year, the drugmaker disclosed that Otezla failed to significantly improve symptoms in patients with ankylosing spondylitis at 16 weeks versus placebo, although "meaningful efficacy" was observed in a subset of patients with early-stage disease at 24 weeks. In addition, the company previously reported positive mid-stage study results for the oral therapy in the treatment of Behçet's disease.
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