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 patients with moderate to severe plaque psoriasis for whom phototherapy or systemic therapy is appropriate. Otezla is the first and only PDE4 inhibitor approved for the treatment of plaque psoriasis. Psoriasis, a chronic inflammatory disease of the skin resulting from an uncontrolled immune response, affects more than 125 million people worldwide.
“Because the product labeling does not require routine laboratory monitoring, oral Otezla may be a welcome new option for patients and physicians looking for a different treatment experience.”
“Otezla offers an important new treatment option for patients whose symptoms are not adequately improving with their current treatments. In clinical trials, Otezla reduced redness, thickness and scaliness of plaques in patients with moderate or severe plaque psoriasis,” said M. Shane Chapman, MD, Section Chief of Dermatology at Dartmouth-Hitchcock Medical Center. “Because the product labeling does not require routine laboratory monitoring, oral Otezla may be a welcome new option for patients and physicians looking for a different treatment experience.”
The approval of Otezla was based primarily on safety and efficacy results from two multi-center, randomized, double-blind, placebo-controlled studies—ESTEEM 1 and ESTEEM 2—conducted in adult patients with moderate to severe plaque psoriasis: body surface area (BSA) involvement of ≥10%, static Physician Global Assessment (sPGA) of ≥3 (moderate or severe disease), Psoriasis Area and Severity Index (PASI) score ≥12, and candidates for phototherapy or systemic therapy.
“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,” said Scott Smith, President Inflammation & Immunology for Celgene Corporation. “The FDA approval of Otezla for plaque psoriasis, together with the previous approval for psoriatic arthritis, reflects Celgene’s commitment to extending the reach of our research and science in an effort to improve the lives of people worldwide living with chronic inflammatory diseases.”
In the ESTEEM studies, Otezlatreatment resulted in significant and clinically meaningful improvements in plaque psoriasis as measured by PASI scores at week 16. Clinical improvement as measured by sPGA scores of clear to almost clear were also demonstrated in both studies.
The safety of Otezla was assessed in 1,426 patients from three clinical trials. Side effects of Otezla were diarrhea, nausea, upper respiratory tract infection, tension headache, and headache. Before starting Otezla, patients should inform their doctor if they have a history of depression or suicidal behavior and if these conditions or other mood changes develop or worsen while taking Otezla. Patients taking Otezla should have their weight checked regularly.
“Psoriasis is a serious autoimmune disorder commonly associated with comorbidities,” said Randy Beranek, president and CEO, National Psoriasis Foundation. “Effectively treating psoriasis is an important part of managing a patient's overall health. Having a new treatment like Otezla is important so patients can have more options and can work closely with their providers to find what works best for them.”
Otezla is available in the U.S. and is 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 844-468-3952 or visit www.otezla.com for more information.
Otezla was approved on March 21, 2014 by the U.S. Food and Drug Administration (FDA) for the treatment of adults with active psoriatic arthritis. A New Drug Submission (NDS) for psoriatic arthritis was submitted to health authorities in Canada in the second quarter of 2013. A NDS for psoriasis in Canada as well as a combined psoriatic arthritis/psoriasis Marketing Authorization Application (MAA) in Europe were all submitted to health authorities in the fourth quarter of 2013.
Patients are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 800-332-1088.
To learn more about the role of PDE4 in inflammatory diseases, go to www.discoverpde4.com. For more information, please visit www.celgene.com.