CIBINQO is a once-daily oral treatment with
proven efficacy to manage symptoms for adults who have not yet
found relief with current options
Pfizer Inc. (NYSE: PFE) announced today that the United States
(U.S.) Food and Drug Administration (FDA) approved CIBINQO®
(abrocitinib), an oral, once-daily, Janus kinase 1 (JAK1)
inhibitor, for the treatment of adults living with refractory,
moderate-to-severe atopic dermatitis (AD) whose disease is not
adequately controlled with other systemic drug products, including
biologics, or when use of those therapies is inadvisable.
CIBINQO is approved at the recommended doses of 100 mg and 200
mg, with the 200 mg dose being recommended for patients who are not
responding to the 100 mg dose. Additionally, a 50 mg dose was
approved to treat moderate-to-severe AD specifically in patients
with moderate renal impairment (kidney failure), certain patients
receiving treatment with inhibitors of cytochrome P450 (CYP) 2C19,
or patients who are known or suspected to be poor metabolizers of
CYP2C19. For patients with moderate renal impairment who are not
responding to 50 mg once daily, 100 mg once daily may also be
prescribed.
“The reality for patients living with chronic inflammatory skin
disease such as moderate-to-severe atopic dermatitis is that many
experience debilitating symptoms that are not managed by current
treatment options. Today’s approval of CIBINQO will provide an
important new oral option that could help those who have yet to
find relief,” said Jonathan Silverberg, MD, PhD, MPH, Department of
Dermatology, The George Washington University School of Medicine
and Health Sciences. “In multiple large-scale clinical trials,
CIBINQO demonstrated strong efficacy at clearing skin, improving
itch, and managing the extent and severity of eczema, offering a
benefit-risk profile that supports the use of this treatment in the
FDA-approved patient population.”
The FDA approval was based on results of five clinical trials
from a large-scale clinical trial program of more than 1,600
patients. The safety and efficacy of CIBINQO was evaluated in three
randomized, placebo-controlled, Phase 3 trials. Additionally,
safety was evaluated through a randomized, placebo-controlled,
dose-ranging trial and an ongoing long-term open-label extension
trial. Across the trials, CIBINQO demonstrated a consistent safety
profile and profound improvements in skin clearance, extent of
disease, and severity, as well as rapid improvement in itch after
two weeks, for some people living with AD versus placebo. In
addition, a higher proportion of subjects treated with CIBINQO in
two monotherapy trials achieved improvement in itching at week 12
compared to placebo.
“The FDA’s approval offers hope to the millions of patients
across the U.S. who are suffering daily with an immuno-inflammatory
condition that can cause intense and persistent itching, pain,
discomfort, and distress if left uncontrolled,” said Mike
Gladstone, Global President of Pfizer Inflammation &
Immunology. “CIBINQO, an efficacious once-daily pill, is a medical
breakthrough made possible by Pfizer researchers and the people
living with moderate-to-severe atopic dermatitis who participated
in our clinical trials.”
“Atopic dermatitis is so much more than just a rash, and it goes
beyond the surface of the skin. It’s a chronic condition that can
both significantly disrupt patients’ daily lives and negatively
impact their emotional well-being,” said Julie Block, President and
CEO, National Eczema Association. “We appreciate Pfizer’s
commitment to this resilient patient community and eagerly await
the positive impact CIBINQO could have on the treatment landscape
for moderate-to-severe atopic dermatitis.”
The most common adverse events reported in ≥5% of patients with
CIBINQO included nasopharyngitis (12.4% with CIBINQO 100 mg, 8.7%
with CIBINQO 200 mg, and 7.9%, with placebo), nausea (6%, 14.5%,
and 2.1%, respectively), and headache (6%, 7.8%, and 3.5%,
respectively).
The full prescribing information for CIBINQO can be found here.
CIBINQO will be made available in the coming weeks.
Additional Details on the CIBINQO Clinical Trial
Program
Five clinical trials in the CIBINQO JAK1 Atopic Dermatitis
Efficacy and Safety (JADE) global development program were included
in the New Drug Application (NDA) to support the FDA approval.
The safety and efficacy of CIBINQO was evaluated in three Phase
3, randomized, placebo-controlled clinical trials. The trials
evaluated measures of improvements in skin clearance, itch, disease
extent, and severity, including the Investigator Global Assessment
(IGA), Eczema Area and Severity Index (EASI), and Peak Pruritus
Numerical Ratings Scale (PP-NRS). In each of the trials, over 40%
of patients had prior exposure to a systemic therapy:
- JADE MONO-1 and JADE MONO-2: A pair of randomized,
double-blind, placebo-controlled trials designed to evaluate the
efficacy and safety of two doses (100 mg and 200 mg once daily) of
CIBINQO monotherapy in 778 patients 12 years of age and older with
moderate-to-severe AD. The trials assessed the co-primary endpoints
of IGA and EASI-75 responses at Week 12.
- JADE COMPARE: A randomized, double-blind, placebo-controlled
trial designed to evaluate the efficacy and safety of two doses
(100 mg and 200 mg once daily) of CIBINQO in 837 adult patients
with moderate-to-severe AD on background topical medicated therapy.
The trial also included an active control arm with dupilumab, a
biologic treatment administered by subcutaneous injection, compared
with placebo. The trial assessed the co-primary endpoints of IGA
and EASI-75 responses at Week 12.
Select findings for CIBINQO 100 mg, 200 mg, and placebo follow
(*p<0.01 or **p<0.001):
- JADE MONO-1:
- IGA Response Rate (Week 12): 24%*, 44%**, and 8%,
respectively
- EASI-75 Response Rate (Week 12): 40%**, 62%**, and 12%,
respectively
- JADE MONO-2
- IGA Response Rate (Week 12): 28%**, 38%**, and 9%,
respectively
- EASI-75 Response Rate (Week 12): 44%**, 61%**, and 10%,
respectively
- JADE COMPARE
- IGA Response Rate (Week 12): 36%**, 47%**, and 14%,
respectively
- EASI-75 Response Rate (Week 12): 58%**, 68%**, and 27%,
respectively
Safety was additionally evaluated through a randomized
dose-ranging trial and a long-term, open-label, extension trial
(JADE EXTEND).
U.S. IMPORTANT SAFETY INFORMATION
WARNING: SERIOUS INFECTIONS, MORTALITY,
MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, AND
THROMBOSIS
Serious Infections
Patients treated with CIBINQO may be at increased risk for
developing serious infections that may lead to hospitalization or
death. The most frequent serious infections reported with CIBINQO
were herpes simplex, herpes zoster, and pneumonia.
If a serious or opportunistic infection develops, discontinue
CIBINQO and control the infection.
Reported infections from Janus kinase (JAK) inhibitors used
to treat inflammatory conditions:
- Active tuberculosis, which may present with pulmonary or
extrapulmonary disease. Test for latent TB before and during
therapy; treat latent TB prior to use. Monitor all patients for
active TB during treatment, even patients with initial negative,
latent TB test.
- Invasive fungal infections, including cryptococcosis and
pneumocystosis. Patients with invasive fungal infections may
present with disseminated, rather than localized, disease.
- Bacterial, viral (including herpes zoster), and other
infections due to opportunistic pathogens.
Avoid use of CIBINQO in patients with an active, serious
infection, including localized infections. The risks and benefits
of treatment with CIBINQO should be carefully considered prior to
initiating therapy in patients with chronic or recurrent
infections or those who have resided or traveled in areas of
endemic tuberculosis or endemic mycoses.
Patients should be closely monitored for the development of
signs and symptoms of infection during and after treatment with
CIBINQO, including the possible development of tuberculosis in
patients who tested negative for latent tuberculosis infection
prior to initiating therapy.
Consider yearly screening for patients in highly endemic areas
for TB. CIBINQO is not recommended for use in patients with active
TB. For patients with a new diagnosis of latent TB or prior
untreated latent TB, or for patients with a negative test for
latent TB but who are at high risk for TB infection, start
preventive therapy for latent TB prior to initiation of
CIBINQO.
Viral reactivation, including herpes virus reactivation (eg,
herpes zoster, herpes simplex), was reported in clinical studies
with CIBINQO. If a patient develops herpes zoster, consider
interrupting CIBINQO until the episode resolves. Hepatitis B virus
reactivation has been reported in patients receiving JAK
inhibitors. Perform viral hepatitis screening and monitoring for
reactivation in accordance with clinical guidelines before starting
therapy and during therapy with CIBINQO. CIBINQO is not recommended
for use in patients with active hepatitis B or hepatitis C.
Mortality
In a large, randomized postmarketing safety study in
rheumatoid arthritis (RA) patients 50 years of age and older with
at least one cardiovascular risk factor comparing another JAK
inhibitor to TNF blocker treatment, a higher rate of all-cause
mortality (including sudden cardiovascular death) was observed with
the JAK inhibitor. CIBINQO is not approved for use in RA
patients.
Malignancies
Malignancies, including non-melanoma skin cancer (NMSC), were
reported in patients treated with CIBINQO. Lymphoma and other
malignancies have been observed in patients receiving JAK
inhibitors used to treat inflammatory conditions. Perform
periodic skin examination for patients who are at increased risk
for skin cancer. Exposure to sunlight and UV light should be
limited by wearing protective clothing and using broad-spectrum
sunscreen.
In a large, randomized postmarketing safety study of another
JAK inhibitor in RA patients, a higher rate of malignancies
(excluding non-melanoma skin cancer [NMSC]) was observed in
patients treated with the JAK inhibitor compared to those treated
with TNF blockers. CIBINQO is not approved for use in RA
patients. A higher rate of lymphomas was observed in patients
treated with the JAK inhibitor compared to those treated with TNF
blockers. A higher rate of lung cancers was observed in current or
past smokers treated with the JAK inhibitor compared to those
treated with TNF blockers. Patients who are current or past
smokers are at additional increased risk.
Consider the benefits and risks for the individual patient prior
to initiating or continuing therapy with CIBINQO, particularly in
patients with a known malignancy (other than a successfully treated
NMSC), patients who develop a malignancy when on treatment, and
patients who are current or past smokers.
Major Adverse Cardiovascular
Events
Major adverse cardiovascular events were reported in patients
treated with CIBINQO. In RA patients 50 years of age and older with
at least one cardiovascular risk factor treated with another JAK
inhibitor, a higher rate of major adverse cardiovascular events
(MACE) (defined as cardiovascular death, myocardial infarction, and
stroke), was observed when compared with TNF blockers. CIBINQO is
not approved for use in RA patients. Patients who are current or
past smokers are at additional increased risk. Discontinue CIBINQO
in patients that have experienced a myocardial infarction or
stroke.
Consider the benefits and risks for the individual patient prior
to initiating or continuing therapy with CIBINQO, particularly in
patients who are current or past smokers and patients with other
cardiovascular risk factors. Patients should be informed about the
symptoms of serious cardiovascular events and the steps to take if
they occur.
Thrombosis
Deep vein thrombosis (DVT) and pulmonary embolism (PE) have
been reported in patients treated with CIBINQO. Thrombosis,
including PE, DVT, and arterial thrombosis have been reported in
patients receiving JAK inhibitors used to treat inflammatory
conditions. Many of these adverse reactions were serious and some
resulted in death. In RA patients 50 years of age and older with at
least one cardiovascular risk factor treated with another JAK
inhibitor, a higher rate of overall thrombosis, DVT, and PE were
observed when compared with TNF blockers. CIBINQO is not
approved for use in RA patients.
Avoid CIBINQO in patients that may be at increased risk of
thrombosis. If symptoms of thrombosis occur, discontinue CIBINQO
and treat patients appropriately.
Contraindication
CIBINQO is contraindicated in patients taking antiplatelet
therapies, except for low-dose aspirin (≤81 mg daily), during the
first 3 months of treatment.
Laboratory Abnormalities
Hematologic Abnormalities:
Treatment with CIBINQO was associated with an increased incidence
of thrombocytopenia and lymphopenia. Prior to CIBINQO initiation,
perform a complete blood count (CBC). CBC evaluations are
recommended at 4 weeks after initiation and 4 weeks after dose
increase of CIBINQO. Discontinuation of CIBINQO therapy is required
for certain laboratory abnormalities.
Lipid Elevations: Dose-dependent
increase in blood lipid parameters were reported in patients
treated with CIBINQO. Lipid parameters should be assessed
approximately 4 weeks following initiation of CIBINQO therapy, and
thereafter patients should be managed according to clinical
guidelines for hyperlipidemia. The effect of these lipid parameter
elevations on cardiovascular morbidity and mortality has not been
determined.
Immunizations
Prior to initiating CIBINQO, complete all age-appropriate
vaccinations as recommended by current immunization guidelines,
including prophylactic herpes zoster vaccinations. Avoid
vaccination with live vaccines immediately prior to, during, and
immediately after CIBINQO therapy.
Renal Impairment
Avoid use in patients with severe renal impairment or end stage
renal disease, including those on renal replacement therapy.
Hepatic Impairment
Avoid use in patients with severe hepatic impairment.
Adverse Reactions
Most common adverse reactions (≥1%) in subjects receiving 100 mg
and 200 mg include: nasopharyngitis, nausea, headache, herpes
simplex, increased blood creatinine phosphokinase, dizziness,
urinary tract infection, fatigue, acne, vomiting, oropharyngeal
pain, influenza, gastroenteritis.
Most common adverse reactions (≥1%) in subjects receiving either
100 mg or 200 mg also include: impetigo, hypertension, contact
dermatitis, upper abdominal pain, abdominal discomfort, herpes
zoster, and thrombocytopenia.
Use in Pregnancy
Available data from pregnancies reported in clinical trials with
CIBINQO are not sufficient to establish a drug-associated risk for
major birth defects, miscarriage, or other adverse maternal or
fetal outcomes. Advise females of reproductive potential that
CIBINQO may impair fertility.
There will be a pregnancy exposure registry that monitors
pregnancy outcomes in women exposed to CIBINQO during pregnancy.
Pregnant women exposed to CIBINQO and health care providers are
encouraged to call 1-877-311-3770.
Lactation
Advise women not to breastfeed during treatment with CIBINQO and
for one day after the last dose.
Indication
CIBINQO is indicated for the treatment of adults with
refractory, moderate to severe atopic dermatitis whose disease is
not adequately controlled with other systemic drug products,
including biologics, or when use of those therapies is
inadvisable.
Limitations of Use: CIBINQO is not recommended for use in
combination with other JAK inhibitors, biologic immunomodulators,
or with other immunosuppressants.
About CIBINQO® (abrocitinib)
CIBINQO is an oral small molecule that selectively inhibits
Janus kinase (JAK) 1. Inhibition of JAK1 is thought to modulate
multiple cytokines involved in pathophysiology of AD, including
interleukin IL-4, IL-13, IL-31, IL-22, and thymic stromal
lymphopoietin (TSLP).
In addition to receiving regulatory approval in the U.S.,
CIBINQO has received marketing authorization in the European Union,
Great Britain, Japan, Korea, the United Arab Emirates, Norway,
Iceland, and Singapore.
About Atopic Dermatitis
AD is a chronic skin disease characterized by inflammation of
the skin and skin barrier defects.i,ii Most people know AD is a
skin condition. But many don’t realize it can be caused in part by
an abnormal immune response beneath the skin. This dysregulated
immune response is thought to contribute to inflammation within the
skin and the signs of AD on the surface. Lesions of AD are
characterized by erythema (red/pink or discolored skin patches,
depending on normal skin color), itching, lichenification
(thick/leathery skin), induration (hardening)/papulation
(formulation of papules), and oozing/crusting.i,ii
AD is one of the most common inflammatory skin diseases,
affecting approximately 5-10% of adults in the U.S.iii,iv
Approximately 1 in 3 adults with AD have moderate-to-severe
disease.v,vi
About Pfizer Inflammation & Immunology
At Pfizer Inflammation & Immunology, we strive to deliver
breakthroughs that enable freedom from day-to-day suffering for
people living with autoimmune and chronic inflammatory diseases,
which can be debilitating, disfiguring and distressing,
dramatically affecting what they can do. With a focus on
immuno-inflammatory conditions in Rheumatology, Gastroenterology
and Medical Dermatology, our current portfolio of approved
medicines and investigational molecules spans multiple action and
delivery mechanisms, from topicals to small molecules, biologics
and biosimilars. The root cause of many immunological diseases is
immuno-inflammation, which requires specifically designed agents.
Our differentiated R&D approach resulted in one of the broadest
pipelines in the industry, where we purposefully match molecules to
diseases where we believe they can make the biggest difference.
Building on our decades-long commitment and pioneering science, we
continue to advance the standard of care for patients living with
immuno-inflammatory diseases and are working hand-in-hand with
patients, caregivers and the broader healthcare community on
healthcare solutions for the many challenges of managing chronic
inflammatory diseases, allowing patients to live their best
lives.
Pfizer Inc.: Breakthroughs that Change Patients’
Lives
At Pfizer, we apply science and our global resources to bring
therapies to people that extend and significantly improve their
lives. We strive to set the standard for quality, safety, and value
in the discovery, development, and manufacture of health care
products, including innovative medicines and vaccines. Every day,
Pfizer colleagues work across developed and emerging markets to
advance wellness, prevention, treatments, and cures that challenge
the most feared diseases of our time. Consistent with our
responsibility as one of the world's premier innovative
biopharmaceutical companies, we collaborate with health care
providers, governments, and local communities to support and expand
access to reliable, affordable health care around the world. For
more than 170 years, we have worked to make a difference for all
who rely on us. We routinely post information that may be important
to investors on our website at www.pfizer.com. In addition, to
learn more, please visit us on www.pfizer.com and follow us on
Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube and like us
on Facebook at Facebook.com/Pfizer.
DISCLOSURE NOTICE: The information contained in this
release is as of January 14, 2022. Pfizer assumes no obligation to
update forward-looking statements contained in this release as the
result of new information or future events or developments.
This release contains forward-looking information about CIBINQO
(abrocitinib), including its potential benefits, an approval in the
U.S. and anticipated product availability, that involves
substantial risks and uncertainties that could cause actual results
to differ materially from those expressed or implied by such
statements. Risks and uncertainties include, among other things,
the uncertainties inherent in research and development, including
the ability to meet anticipated clinical endpoints, commencement
and/or completion dates for our clinical trials, regulatory
submission dates, regulatory approval dates and/or launch dates, as
well as the possibility of unfavorable new clinical data and
further analyses of existing clinical data; the risk that clinical
trial data are subject to differing interpretations and assessments
by regulatory authorities; whether regulatory authorities will be
satisfied with the design of and results from our clinical studies;
whether and when drug applications may be filed in any other
jurisdictions for any potential indication for CIBINQO; whether and
when any such other applications that may be pending or filed for
CIBINQO may be approved by regulatory authorities, which will
depend on myriad factors, including making a determination as to
whether the product's benefits outweigh its known risks and
determination of the product's efficacy and, if approved, whether
CIBINQO will be commercially successful; decisions by regulatory
authorities impacting labeling, manufacturing processes, safety
and/or other matters that could affect the availability or
commercial potential of CIBINQO; uncertainties regarding the
commercial or other impact of the results of Janus kinase (JAK)
inhibitor studies and data and actions by regulatory authorities
based on analysis of such studies and data, which will depend, in
part, on benefit-risk assessments and labeling determinations;
uncertainties regarding the impact of COVID-19 on our business,
operations, and financial results; and competitive
developments.
A further description of risks and uncertainties can be found in
Pfizer’s Annual Report on Form 10-K for the fiscal year ended
December 31, 2020 and in its subsequent reports on Form 10-Q,
including in the sections thereof captioned “Risk Factors” and
“Forward-Looking Information and Factors That May Affect Future
Results”, as well as in its subsequent reports on Form 8-K, all of
which are filed with the U.S. Securities and Exchange Commission
and available at www.sec.gov and www.pfizer.com.
i Hanifin JM, Reed ML. A population-based survey of eczema in
the United States. Dermatitis. 2007;18(2):82-91. ii Bieber T.
Atopic dermatitis. Dermatology. 2012;1(3):203-217. iii Oszukowska
M, Michalak I, Gutfreund K, et al. Role of primary and secondary
prevention in atopic dermatitis. Postep Derm Alergol.
2015:32(6):409-420. iv Kim BE, Leung DYM. Significance of Skin
Barrier Dysfunction in Atopic Dermatitis. Allergy Asthma Immunol
Res. 2018;10(3):207-215. doi:10.4168/aair.2018.10.3.207. v
Silverberg JI. Public health burden and epidemiology of atopic
dermatitis. Dermatol Clin. 2017;35:283-289. vi Chiesa Fuxench ZC,
Block JK, Boguniewicz M, et al. Atopic dermatitis in America study:
a cross-sectional study examining the prevalence and disease burden
of atopic dermatitis in the US adult population. J Invest Dermatol.
2019;139(3):583-590.
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