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Apremilast is now known as Otezla after getting FDA approval for psoriatic arthritis.
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Celgene Corporation today announced that the U.S. Food and Drug Administration (FDA) has approved OTEZLA® (apremilast), the Company's oral, selective inhibitor of phosphodiesterase 4 (PDE4), for the treatment of adult patients with active psoriatic arthritis.
"OTEZLA works differently from other therapies approved for psoriatic arthritis through the intracellular inhibition of PDE4," said Philip Mease, MD, Director of the Rheumatology Clinical Research Division of Swedish Medical Center and Clinical Professor, University of Washington. "The approval of an oral therapy with a novel mechanism of action for patients with psoriatic arthritis offers a different approach to patient care."
The approval was based on safety and efficacy results from three multi-center, randomized, double-blind, placebo-controlled trials.
"Patients and physicians have expressed their desire for a safe and effective therapy for psoriatic arthritis that has the potential to simplify patient management. Celgene is excited to be expanding our transformational science into the therapeutic realm of Inflammation and Immunology, with a new approach for patients with psoriatic arthritis," said Scott Smith, Global Head, Inflammation and Immunology, Celgene Corporation. "The FDA approval of OTEZLA is good news for patients and healthcare professionals who are looking for a different way to manage this disease."
OTEZLA® (apremilast) is expected to be available in the U.S. in March 2014 and will be dispensed through a comprehensive network of specialty pharmacies. For more information about OTEZLA distribution and the exclusive treatment support services (including reimbursement assistance and 24/7 nurse support), doctors and patients can contact Otezla SupportPlus™ at 1-844-4OTEZLA (1-844-468-3952) or visit [web]www.OTEZLA.com[/web] for more information.
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You can read about the studies here: Apremilast first phase 3 results