The first oral treatment in 25 years for
patients in Japan with these diseases
Celgene Corporation (NASDAQ:CELG) today announced that OTEZLA®
(apremilast), Celgene’s oral selective inhibitor of
phosphodiesterase 4 (PDE4), has been granted full marketing
authorization by Japan’s Ministry of Health, Labor and Welfare
(MHLW) for the treatment of adult patients with plaque psoriasis
with an inadequate response to topical therapies, as well as adult
patients with psoriatic arthritis.
“The approval of the first oral treatment in 25 years for
psoriasis is good news. OTEZLA® has a novel mechanism of action, is
well tolerated and does not require monitoring before
administration. We are pleased that OTEZLA® presents a new
treatment option for patients,” said Mamitaro Ohtsuki, M.D., Ph.D.,
Professor and Chairman, Department of Dermatology, Jichi Medical
University.
OTEZLA® is the first in a new class of medicines approved for
the treatment of both psoriasis and psoriatic arthritis, two
diseases involving dysregulated immune system activity. Plaque
psoriasis is a systemic inflammatory condition characterized by
raised scaly lesions on the skin. It affects an estimated 430,000
people in Japan and about 125 million people worldwide.
The approval was based on efficacy and safety results from an
international phase 2b study (PSOR-005), international phase 3
studies, ESTEEM-1 and 2, and a Japanese phase 2b study (PSOR-011)
conducted in adult patients with moderate to severe plaque
psoriasis, and international phase 3 studies, PALACE-1,2 and 3,
conducted in adult patients with psoriatic arthritis. In clinical
studies, the most common side effects of OTEZLA® were diarrhea,
nausea, upper respiratory tract infection, tension headache, and
headache.
“The approval of OTEZLA® in Japan is another important milestone
for Celgene in its mission to deliver innovative medicines in an
effort to address the unmet needs of people worldwide living with
chronic inflammatory diseases,” said Scott Smith, President,
Celgene Inflammation & Immunology. “We believe that OTEZLA®’s
novel mechanism of action and oral administration will be a welcome
new option for patients with plaque psoriasis and psoriatic
arthritis in Japan.”
OTEZLA® is approved in 37 countries, including the United States
and Europe, as of December 2016.
About OTEZLA®
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.
Important Safety Information
Contraindications
Otezla® (apremilast) is contraindicated in patients with a known
hypersensitivity to apremilast or to any of the excipients in the
formulation.
Warnings and Precautions
Depression: Carefully weigh the risks and benefits of treatment
with Otezla for patients with a history of depression and/or
suicidal thoughts/behavior, or in patients who develop such
symptoms while on Otezla. Patients, caregivers, and families should
be advised of the need to be alert for the emergence or worsening
of depression, suicidal thoughts or other mood changes, and they
should contact their healthcare provider if such changes occur.
Psoriasis: Treatment with Otezla is
associated with an increase in adverse reactions of depression.
During clinical trials, 1.3% (12/920) of patients treated with
Otezla reported depression compared to 0.4% (2/506) on placebo;
0.1% (1/1308) of Otezla patients discontinued treatment due to
depression compared with none on placebo (0/506). Depression was
reported as serious in 0.1% (1/1308) of patients exposed to Otezla,
compared to none in placebo-treated patients (0/506). Suicidal
behavior was observed in 0.1% (1/1308) of patients on Otezla,
compared to 0.2% (1/506) on placebo. One patient treated with
Otezla attempted suicide; one patient on placebo committed
suicide.
Psoriatic Arthritis: During
clinical trials, 1.0% (10/998) of patients treated with Otezla
reported depression or depressed mood compared to 0.8% (4/495)
treated with placebo; 0.3% (4/1441) of patients treated with Otezla
discontinued treatment due to depression or depressed mood compared
with none in placebo treated patients (0/495). Depression was
reported as serious in 0.2% (3/1441) of patients exposed to Otezla,
compared to none in placebo treated patients (0/495). Suicidal
ideation and behavior were observed in 0.2% (3/1441) of patients on
Otezla, compared to none on placebo (0/495). Two patients who
received placebo committed suicide compared to none on Otezla.
Weight Decrease: Monitor body weight regularly; evaluate
unexplained or clinically significant weight loss, and consider
discontinuation of Otezla.
Psoriasis: Body weight loss of
5-10% occurred in 12% (96/784) of patients treated with Otezla and
in 5% (19/382) of patients treated with placebo. Body
weight loss of ≥10% occurred in 2% (16/784) of patients treated
with Otezla compared to 1% (3/382) of patients treated with
placebo.
Psoriatic Arthritis: Body weight
loss of 5-10% was reported in 10% of patients taking Otezla and in
3.3% of patients taking placebo. Monitor body weight
regularly; evaluate unexplained or clinically significant weight
loss, and consider discontinuation of Otezla.
Drug Interactions: Apremilast exposure was decreased when Otezla
was co-administered with rifampin, a strong CYP450 enzyme inducer;
loss of Otezla efficacy may occur. Concomitant use of Otezla with
CYP450 enzyme inducers (e.g. rifampin, phenobarbital,
carbamazepine, phenytoin) is not recommended.
Adverse Reactions
Psoriasis: Adverse reactions
reported in ≥5% of patients were (Otezla%, placebo%): diarrhea
(17, 6), nausea (17, 7), upper respiratory tract infection (9,
6), tension headache (8, 4), and headache (6, 4).
Psoriatic Arthritis: Adverse
reactions reported in ≥2% of patients taking Otezla, that occurred
at a frequency at least 1% higher than that observed in
patients taking placebo, for up to 16 weeks (after the initial
5-day titration), were (Otezla%, placebo%): diarrhea (7.7,
1.6); nausea (8.9, 3.1); headache (5.9, 2.2); upper respiratory
tract infection (3.9, 1.8); vomiting (3.2, 0.4); nasopharyngitis
(2.6, 1.6); upper abdominal pain (2.0, 0.2).
Use in Specific
Populations
Pregnancy and Nursing Mothers: Otezla is Pregnancy Category C;
it has not been studied in pregnant women. Use during pregnancy
only if the potential benefit justifies the potential risk to the
fetus. It is not known whether apremilast or its metabolites are
present in human milk. Caution should be exercised when Otezla is
administered to a nursing woman.
Renal Impairment: Otezla dosage should be reduced in patients
with severe renal impairment (creatinine clearance less than 30
mL/min); for details, see Dosage and Administration,
Section 2, in the Full Prescribing Information.
Please click here for Full Prescribing
Information.
About Psoriasis
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.
About Psoriatic Arthritis
Psoriatic arthritis is a painful, chronic inflammatory disease
characterized by pain, stiffness, swelling and tenderness of the
joints, inflammation of specific ligaments and tendons, and
decrease in physical functioning. It is estimated that nearly 38
million people worldwide have psoriatic arthritis. Psoriatic
arthritis can impact day-to-day activities and has been reported to
increase work disability. Common signs and symptoms of psoriatic
arthritis include pain, stiffness, and swelling in joints.
About Celgene
Celgene Corporation, headquartered in Summit, New Jersey, is an
integrated global biopharmaceutical company engaged primarily in
the discovery, development and commercialization of innovative
therapies for the treatment of cancer and inflammatory diseases
through next-generation solutions in protein homeostasis,
immuno-oncology, epigenetics, immunology and neuro-inflammation.
For more information, please visit www.celgene.com. Follow
Celgene on Social Media: @Celgene, Pinterest, LinkedIn, Facebook
and YouTube.
Forward-Looking Statements
This press release contains forward-looking statements, which
are generally statements that are not historical facts.
Forward-looking statements can be identified by the words
“expects,” “anticipates,” “believes,” “intends,” “estimates,”
“plans,” “will,” “outlook” and similar expressions. Forward-looking
statements are based on management’s current plans, estimates,
assumptions and projections, and speak only as of the date they are
made. Celgene undertakes no obligation to update any
forward-looking statement in light of new information or future
events, except as otherwise required by law. Forward-looking
statements involve inherent risks and uncertainties, most of which
are difficult to predict and are generally beyond Celgene’s
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 Celgene’s Annual Report on Form 10-K and our other
reports filed with the U.S. Securities and Exchange Commission.
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Celgene CorporationInvestors:Patrick E. Flanigan III,
908-673-9969Corporate Vice President, Investor
RelationsorMedia:Catherine Cantone, 908-897-4256Senior Director,
Corporate Communications
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