In phase III studies, OTEZLA resulted in significant and clinically meaningful improvements in plaque psoriasis
OTEZLA demonstrated a consistent safety and tolerability profile across clinical trials
"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 Dr.
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
In the ESTEEM studies, OTEZLA treatment resulted in significant and
clinically meaningful improvements in plaque psoriasis as measured by
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
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 1-844-4OTEZLA (1-844-468-3952) or visit www.OTEZLA.com for more information.
OTEZLA was approved on
Note to editors: Additional information can be found at http://smp.businesswire.com/pages/oral-otezla-apremilast-approved-us-food-and-drug-administration-treatment-patients-moderate.
ESTEEM 1 and 2 are two large pivotal phase III randomized,
placebo-controlled studies evaluating OTEZLA in patients with a
diagnosis of moderate to severe plaque psoriasis for at least 12 months
prior to screening, and who were also candidates for phototherapy and/or
systemic therapy. Approximately 1,250 patients were randomized 2:1 to
receive either OTEZLA 30 mg twice daily or placebo after an initial
five-day titration period, for the first 16 weeks, followed by a
maintenance phase from weeks 16-32 in which placebo patients were
switched to OTEZLA 30 mg twice daily through week 32, and a randomized
withdrawal phase for responders from week 32 to week 52 based on their
initial OTEZLA randomization and
OTEZLA is an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) specific for cyclic adenosine monophosphate (cAMP). PDE4 inhibition results in increased intracellular cAMP levels which is thought to indirectly modulate the production of inflammatory mediators. The specific mechanism(s) by which OTEZLA exerts its therapeutic action in patients with psoriasis or psoriatic arthritis is not well defined.
OTEZLA® (apremilast) is indicated for the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
OTEZLA is also indicated for the treatment of adult patients with active psoriatic arthritis.
ADDITIONAL IMPORTANT SAFETY INFORMATION
Patients who are allergic to apremilast or to any of the ingredients in OTEZLA should not take OTEZLA. Certain medicines should not be taken when on OTEZLA as they may decrease its effectiveness. Patients should tell their doctor about all the medicines they take, including prescription and nonprescription medicines. Women should inform their doctor if they are pregnant, planning to become pregnant, or planning to breastfeed. OTEZLA has not been studied in pregnant women or in women who are breastfeeding. These are not all the possible side effects with OTEZLA. Patients should ask their doctor about other potential side effects and tell their doctor about any side effect that bothers them or does not go away.
Patients are encouraged to report negative side effects of prescription
drugs to the
Psoriasis is an immune-mediated, non-contagious chronic inflammatory skin disorder of unknown cause. The disorder is a chronic recurring condition which varies in severity from minor localized patches to complete body coverage. Plaque psoriasis is the most common type of psoriasis. About 80 percent of people who develop psoriasis have plaque psoriasis, which appears as patches of raised, reddish skin covered by silvery-white scales. These patches, or plaques, frequently form on the elbows, knees, lower back, and scalp. Psoriasis occurs nearly equally in males and females. An estimated 125 million people worldwide have psoriasis. To learn more about the role of PDE4 in inflammatory diseases, go to www.discoverpde4.com.
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statements can be identified by the words "expects," "anticipates,"
"believes," "intends," "estimates," "plans," "will," "outlook" and
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speak only as of the date they are made. We undertake no obligation to
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difficult to predict and are generally beyond our control. Actual
results or outcomes may differ materially from those implied by the
forward-looking statements as a result of the impact of a number of
factors, many of which are discussed in more detail in our Annual Report
on Form 10-K and other reports filed with the
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