OTEZLA reduced the number and pain of oral
ulcers in the 12-week placebo-controlled Phase 3 RELIEF™ study
With this third indication in the U.S., OTEZLA
is the first and only treatment approved for oral ulcers associated
with Behçet’s Disease
Celgene Corporation (NASDAQ:CELG) today announced that the U.S.
Food and Drug Administration (FDA) has approved OTEZLA®
(apremilast) 30 mg twice daily (BID) for the treatment of adult
patients with oral ulcers associated with Behçet’s Disease. OTEZLA,
an oral, selective inhibitor of phosphodiesterase 4 (PDE4), is the
first and only approved treatment option for oral ulcers associated
with Behçet’s Disease, a rare, chronic, multisystem inflammatory
disease that is difficult to treat.
“Oral ulcers are a recurring and debilitating manifestation that
affects nearly everyone living with Behçet’s Disease, and have an
important negative impact on the quality of life for these
patients,” said Yusuf Yazici, M.D., Clinical Associate Professor,
Department of Medicine, New York University Langone Health. “In the
clinical trial, OTEZLA demonstrated improvements in measures of
oral ulcers at week 12. OTEZLA has the potential to be a needed
treatment option for U.S. patients and their physicians, who
previously had limited options available.”
Behçet’s Disease, also known as Behçet’s Syndrome, affects
approximately 5 in 100,000 people in the U.S.1,2 Oral ulcers, the
most common manifestation of Behçet’s Disease occurring in more
than 98% of patients, can be painful, disabling and negatively
affect quality of life.3
“We are excited to provide the first and only FDA-approved
treatment for oral ulcers associated with Behçet’s Disease,” said
Terrie Curran, President, Celgene Inflammation & Immunology.
“This approval is a reflection of Celgene’s commitment to research
in areas of high unmet need, including rare diseases such as
Behçet’s Disease. We remain dedicated to further studying OTEZLA
and its role in inflammatory conditions.”
The FDA approval was based on efficacy and safety results from
the randomized, placebo-controlled, double-blind Phase 3 RELIEF™
study evaluating OTEZLA in 207 adult patients with Behçet’s Disease
with active oral ulcers who were previously treated with at least
one nonbiologic medication and were candidates for systemic
therapy. Results showed OTEZLA 30 mg BID resulted in a 42.7 point
reduction from baseline in the pain of oral ulcers as measured by
the visual analog scale (VAS) at week 12, compared with an 18.7
point reduction with placebo. The proportion of patients achieving
an oral ulcer complete response (oral ulcer-free) at week 12 was
52.9% in the OTEZLA arm and 22.3% in the placebo arm. The
proportion of patients achieving oral ulcer complete response by
week 6 and who remained oral ulcer-free for at least six additional
weeks during the 12-week treatment phase was 29.8% in the OTEZLA
arm and 4.9% in the placebo arm. The daily average number of oral
ulcers during the 12-week treatment phase was 1.5 in the OTEZLA arm
and 2.6 in the placebo arm (based on oral ulcer counts measured at
baseline and at weeks 1, 2, 4, 6, 8, 10 and 12).
“Behçet’s Disease is a chronic inflammatory disease in which
patients present with symptoms such as oral ulcers that can have a
significant impact on daily life,” said Mirta Avila Santos, M.D.,
Executive Director, American Behçet’s Disease Association. “Today’s
approval for OTEZLA marks an important milestone for people with
Behçet’s Disease who have been eagerly waiting for treatment
options for their oral ulcers.”
The most common adverse events observed occurring in ≥10% of
patients in the RELIEF trial were diarrhea (41.3% with OTEZLA;
20.4% for placebo), nausea (19.2% with OTEZLA; 10.7% for placebo),
headache (14.4% with OTEZLA; 10.7% for placebo) and upper
respiratory tract infection (11.5% with OTEZLA; 4.9% for placebo).
The safety profile was consistent with the known safety profile of
OTEZLA.
OTEZLA is now approved for three indications in the U.S.,
including the treatment of patients with moderate to severe plaque
psoriasis who are candidates for phototherapy or systemic therapy,
adult patients with active psoriatic arthritis and adult patients
with oral ulcers associated with Behçet’s Disease. Since its
initial FDA approval in 2014, OTEZLA has been prescribed to more
than 250,000 patients with moderate to severe plaque psoriasis or
active psoriatic arthritis in the U.S.4
OTEZLA is available in the U.S. and is dispensed through a
comprehensive network of specialty pharmacies. For more information
about accessing OTEZLA and patient 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.
Celgene anticipates a regulatory decision for OTEZLA in oral
ulcers associated with Behçet’s Disease from the Pharmaceuticals
and Medical Devices Agency in Japan in the second half of 2019. The
Company also submitted a Type II Variation to the Marketing
Authorization Application earlier this year seeking approval in the
European Union.
About the RELIEF™ Study
The RELIEF™ study is a Phase 3 randomized, placebo-controlled,
double-blind study evaluating OTEZLA 30 mg BID in 207 adult
patients with Behçet’s Disease with active oral ulcers who were
previously treated with at least one nonbiologic medication and
were candidates for systemic therapy. This 64-week study was
conducted at 53 sites across 10 countries.
In the study, 207 adult patients were randomized 1:1 to receive
either OTEZLA 30 mg BID (n=104) or placebo (n=103) for the 12-week
placebo-controlled treatment phase. Upon completion of week 12, all
patients received OTEZLA for the 52-week active treatment phase.
Efficacy was assessed based on the number and pain of oral ulcers,
including the daily average number of oral ulcers during the
12-week placebo-controlled treatment phase.
About Behçet’s Disease
Behçet’s Disease is associated with abnormalities of the immune
system and inflammation of the blood vessels. Behçet’s Disease is
characterized by recurrent oral and genital ulcers, skin lesions,
uveitis, arthritis, vascular, central nervous system and
gastrointestinal involvement. Oral ulcers are present in more than
98% of Behçet’s Disease patients.
Behçet’s Disease has been classified in the U.S. as a rare or
“orphan” disease by the National Institutes of Health. At this
time, there are limited approved therapies to treat Behçet’s
Disease in the U.S. Prevalence of Behçet’s Disease is highest in
the Middle East, Asia and Japan.
About OTEZLA® (apremilast)
OTEZLA® (apremilast) 30 mg tablets 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 is not well defined.
U.S. PRESCRIBING INFORMATION
INDICATIONS
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 indicated for the treatment of adult patients with
active psoriatic arthritis.
Otezla is indicated for the treatment of adult patients with
oral ulcers associated with Behçet’s Disease.
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
Diarrhea, Nausea and Vomiting: Cases of severe diarrhea, nausea,
and vomiting were associated with the use of Otezla. Most events
occurred within the first few weeks of treatment. In some cases
patients were hospitalized. Patients 65 years of age or older and
patients taking medications that can lead to volume depletion or
hypotension may be at a higher risk of complications from severe
diarrhea, nausea, or vomiting. Monitor patients who are more
susceptible to complications of diarrhea or vomiting; advise
patients to contact their healthcare provider. Consider Otezla dose
reduction or suspension if patients develop severe diarrhea,
nausea, or vomiting
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 depression. During clinical trials,
1.3% (12/920) of patients reported depression compared to 0.4%
(2/506) on placebo. 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: Treatment with
Otezla is associated with an increase in depression. During
clinical trials, 1.0% (10/998) reported depression or depressed
mood compared to 0.8% (4/495) treated with placebo. Suicidal
ideation and behavior was observed in 0.2% (3/1441) of patients on
Otezla, compared to none in placebo-treated patients. Depression
was reported as serious in 0.2% (3/1441) of patients exposed to
Otezla, compared to none in placebo-treated patients (0/495). Two
patients who received placebo committed suicide compared to none on
Otezla.
Behçet’s Disease: Treatment with
Otezla is associated with an increase in depression. During the
clinical trial, 1% (1/104) reported depression or depressed mood
compared to 1% (1/103) treated with placebo. No instances of
suicidal ideation or behavior were reported in patients treated
with Otezla or treated with placebo.
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% (49/497) of patients taking
Otezla and in 3.3% (16/495) of patients taking placebo.
Behçet’s Disease: Body weight loss
of >5% was reported in 4.9% (5/103) of patients taking Otezla
and in 3.9% (4/102) of patients taking placebo.
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 at least 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)
Behçet’s Disease: Adverse reactions
reported in at least ≥5% of patients taking Otezla, that occurred
at a frequency at least 1% higher than that observed in patients
taking placebo, for up to 12 weeks were (Otezla%, placebo%):
diarrhea (41.3, 20.4); nausea (19.2, 10.7); headache (14.4, 10.7);
upper respiratory tract infection (11.5, 4.9); upper abdominal pain
(8.7, 1.9), vomiting (8.7, 1.9); back pain (7.7, 5.8); viral upper
respiratory tract infection (6.7, 4.9); arthralgia (5.8, 2.9).
Use in Specific
Populations
Pregnancy: Otezla has not been studied in pregnant women. Advise
pregnant women of the potential risk of fetal loss. Consider
pregnancy planning and prevention for females of reproductive
potential. There is a pregnancy exposure registry that monitors
pregnancy outcomes in women exposed to Otezla during pregnancy.
Information about the registry can be obtained by calling
1-877-311-8972 or visiting
https://mothertobaby.org/ongoing-study/otezla/.
Lactation: There are no data on the presence of apremilast or
its metabolites in human milk, the effects of apremilast on the
breastfed infant, or the effects of the drug on milk production.
The developmental and health benefits of breastfeeding should be
considered along with the mother’s clinical need for Otezla and any
potential adverse effects on the breastfed child from Otezla or
from the underlying maternal condition.
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 Celgene
Celgene Corporation, headquartered in Summit, New Jersey, is an
integrated global pharmaceutical 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. We undertake 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 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 our other reports filed with the U.S.
Securities and Exchange Commission, including factors related to
the proposed transaction between Bristol-Myers Squibb and Celgene,
such as, but not limited to, the risks that: management’s time and
attention is diverted on transaction related issues; disruption
from the transaction make it more difficult to maintain business,
contractual and operational relationships; legal proceedings are
instituted against Bristol-Myers Squibb, Celgene or the combined
company that could delay or prevent the proposed transaction; and
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retain key personnel.
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purposes only. Celgene bears no responsibility for the security or
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All trademarks are the property of their respective owners.
###
1 Zeidan MJ, Saadoun D, Garrido M , Klatzmann D, Six A, Cacoub
P. Behçet’s disease physiopathology: a contemporary review.
Autoimmun Highlights. 2016;7(1):4. 2 Leonardo NM, McNeil J.
Behçet’s disease: is there geographical variation? A review far
from the Silk Road. Int J Rheumatol. 2015;2015:945262. 3 Medscape
EMedicine. Dermatological Aspects of Behcet Disease Clinical
Presentation.
https://emedicine.medscape.com/article/1122381-clinical. Accessed
February 2019. 4 Symphony Health Solution PrescriberSource
PatientFocus, Includes all prescriptions from April 2014 through
April 2019.
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