- VELSIPITY is the first and only oral advanced ulcerative
colitis therapy approved for use in patients 16 years of age or
older in the EU
Pfizer Inc. (NYSE: PFE) announced today that the European
Commission (EC) has granted marketing authorization for VELSIPITY®
(etrasimod) in the European Union to treat patients 16 years of age
and older with moderately to severely active ulcerative colitis
(UC) who have had an inadequate response, lost response, or were
intolerant to either conventional therapy, or a biological
agent.
“For the 2.6 million people in Europe living with UC, the
unpredictable physical, mental, and emotional impacts of the
condition can be debilitating. They may cycle through several
different conventional treatment options to find relief for their
symptoms,” said Séverine Vermeire, MD, PhD, Professor of Medicine
at KU Leuven and an investigator in the ELEVATE Registrational
Program. “The approval of VELSIPITY helps bridge the gap for those
with moderately to severely active UC who need an effective
advanced treatment but may be apprehensive about using injectable
therapies like biologics.”
The marketing authorization for VELSIPITY is valid in all 27 EU
member states as well as Iceland, Liechtenstein, and Norway. This
authorization follows the recommendation for approval by the
European Medicines Agency’s (EMA) Committee for Medicinal Products
for Human Use (CHMP) in December 2023. It also follows VELSIPITY’s
approval for adults with moderately to severely active UC by the
U.S. Food and Drug Administration (FDA) in October 2023, and for
adults with moderately to severely active UC who have had an
inadequate response, lost response, or were intolerant to either
conventional therapy or an advanced treatment in Canada in January
2024. Regulatory applications for VELSIPITY in UC have been
submitted to additional countries around the world for review.
“VELSIPITY can help appropriate patients with UC who are
struggling to achieve remission on conventional therapies,” said
Alexandre de Germay, Chief International Commercial Officer,
Executive Vice President, Pfizer. “With convenient, once-daily oral
dosing and a favorable benefit-risk profile, VELSIPITY is an
attractive potential treatment option and Pfizer is proud to bring
this medicine to appropriate UC patients as young as 16 years old
in the European Union.”
The approval was based on results from the ELEVATE UC Phase 3
registrational program (ELEVATE UC 52 and ELEVATE UC 12) that
evaluated the safety and efficacy of VELSIPITY 2 mg once-daily on
clinical remission in UC patients who had previously failed or were
intolerant to at least one conventional, biologic, or Janus kinase
(JAK) inhibitor therapy. Additionally, ELEVATE UC 52 and ELEVATE UC
12 were the only studies of advanced therapies for UC to include
patients with isolated proctitis, which affects approximately 30%
of those diagnosed with UC. Both studies achieved all primary and
key secondary efficacy endpoints, with a favorable safety profile
consistent with previous studies of VELSIPITY. VELSIPITY also
demonstrated improvement in the total inflammatory bowel disease
questionnaire score, which measures health-related quality of life.
The most common adverse reactions were lymphopenia (11%) and
headache (7%).
About Ulcerative Colitis
UC is a chronic, immune-mediated inflammatory bowel disease
characterized by diffuse mucosal inflammation.1 Clinical symptoms
of UC may include but are not limited to frequent diarrhea, bowel
urgency, rectal bleeding, abdominal pain, fatigue, fever and
anemia.2,3,4 Its impact can span beyond the physical to other
aspects of life due to the chronic and unpredictable nature of
symptoms.5,6
About VELSIPITY® (etrasimod)
VELSIPITY is a once-daily, oral, sphingosine 1-phosphate (S1P)
receptor modulator that selectively binds with S1P receptor
subtypes 1, 4, and 5. Regulatory applications for VELSIPITY in
ulcerative colitis have been submitted to additional countries
including Australia, India, Mexico, Russia, Singapore, Switzerland,
Turkey, and the UK.
U.S. INDICATION
VELSIPITY is a selective sphingosine-1-phosphate (S1P) receptor
modulator indicated for the treatment of moderately to severely
active UC in adults.
U.S. IMPORTANT SAFETY INFORMATION & INDICATION
Do not take VELSIPITY if you:
- have had a heart attack, chest pain (unstable angina), stroke
or mini stroke (transient ischemic attack or TIA), and certain
types of heart failure requiring hospitalization in the last 6
months
- have or have had a history of unusual heartbeats (arrhythmia)
that is not corrected by a pacemaker
Talk to your healthcare provider before taking VELSIPITY if you
have any of these conditions or do not know if you have any of
these conditions.
VELSIPITY can cause serious side effects, including:
- Infections: VELSIPITY can increase your risk of serious
infections. These infections can be life-threatening and cause
death. VELSIPITY lowers the number of white blood cells
(lymphocytes) in your blood. This usually returns to normal within
4 to 5 weeks after you stop taking VELSIPITY. Your healthcare
provider will test your blood before you start taking VELSIPITY.
Your healthcare provider may delay or stop your VELSIPITY treatment
if you have an infection. Call your healthcare provider right away
if you have any of these symptoms of an infection during treatment
with VELSIPITY, and for 5 weeks after you stop taking VELSIPITY:
fever or high temperature, pain when peeing or peeing more often
than usual as these can be signs of a urinary tract infection,
tiredness, flu-like symptoms, or headache with fever, neck
stiffness, sensitivity to light, nausea, or confusion as these may
be symptoms of meningitis, an infection of the lining around your
brain and spine.
- Slow heart rate (also known as bradyarrhythmia) when you
start taking VELSIPITY: VELSIPITY may cause your heart rate to
temporarily slow down especially after you take your first dose.
You will have a test called an electrocardiogram (ECG) to check the
electrical activity of your heart before you take your first dose
of VELSIPITY. Call your healthcare provider if you experience these
symptoms of slow heart rate: feeling dizzy, feeling lightheaded,
feeling like your heart is beating slowly or skipping beats,
feeling short of breath, feeling confused, feeling tired, or chest
pain.
Before taking VELSIPITY, tell your healthcare provider about
all of your medical conditions, including if you:
- have a serious infection or an infection that does not go away
or that keeps coming back (chronic).
- are unable to fight infections due to a disease.
- have received a vaccine in the past 4 weeks or are scheduled to
receive a vaccine. You should be brought up to date with all
age-required vaccines before starting treatment with VELSIPITY.
VELSIPITY may affect how well a vaccine works. Tell your healthcare
provider that you are receiving treatment with VELSIPITY before
receiving a vaccine.
- have chickenpox or received the vaccine for chickenpox. Your
healthcare provider may do a blood test for the chickenpox virus.
You may need to get the full course of the chickenpox vaccine and
then wait 4 weeks before you start taking VELSIPITY.
- have a slow heart rate.
- have an irregular or abnormal heartbeat (arrhythmia).
- have heart disease, Class I or II heart failure, history of a
heart attack, high blood pressure or uncontrolled high blood
pressure.
- have cerebrovascular disease or history of a stroke or
ministroke.
- history of repeated fainting.
- have or have had liver problems.
- have or have had skin cancer.
- have breathing problems, including untreated sleep apnea.
- are pregnant or plan to become pregnant. VELSIPITY may harm
your unborn baby. Talk with your healthcare provider if you are
pregnant or plan to become pregnant. If you are a female who can
become pregnant, talk with your healthcare provider and use
effective birth control during your treatment with VELSIPITY and
for 7 days after you stop taking VELSIPITY. If you become pregnant
while taking VELSIPITY or within 7 days after you stop taking
VELSIPITY, talk with your healthcare provider and enroll in the
VELSIPITY Pregnancy Registry by calling 1-800-616-3791.
- are breastfeeding or plan to breastfeed. It is not known if
VELSIPITY passes into your breast milk. Talk to your healthcare
provider about the best way to feed your baby if you take
VELSIPITY.
Tell your healthcare provider about all the medicines you
take, including prescription and over-the-counter medicines,
vitamins, and herbal supplements. Using VELSIPITY with other
medicines can cause serious side effects. Especially tell your
healthcare provider if you take or have taken:
- medicines to control your heart rhythm (antiarrhythmics),
heartbeat, or blood pressure. These may be called beta blockers or
calcium channel blockers.
- medicines that affect your immune system.
- certain medicines known as moderate to strong inhibitors of
both CYP2C9 and CYP3A4, medicines such as fluconazole. If you are
taking fluconazole, you should not take VELSIPITY.
- Rifampin. If you are taking rifampin, you should not take
VELSIPITY.
You should not receive live vaccines at least 4 weeks
before starting VELSIPITY, during treatment with VELSIPITY and for
5 weeks after you stop taking VELSIPITY. Talk to your healthcare
provider before you receive a vaccine during treatment and for 5
weeks after treatment with VELSIPITY. If you receive a live
vaccine, you may get the infection the vaccine was meant to
prevent. Vaccines may not work as well when given during treatment
with VELSIPITY.
VELSIPITY can cause serious side effects, including:
- Liver problems. VELSIPITY may cause liver problems. Your
healthcare provider will do blood tests to check your liver before
you start taking VELSIPITY. Call your healthcare provider right
away if you have any of the following symptoms: unexplained nausea,
vomiting, stomach area (abdominal pain), tiredness, loss of
appetite, yellowing of the whites of your eyes or skin, or
dark-colored urine.
- Increased blood pressure. Your healthcare provider
should check your blood pressure during treatment with VELSIPITY
and treat you as needed.
- A problem with your vision called macular edema. Your
healthcare provider should test your vision around the time you
start taking VELSIPITY or at any time you notice vision changes
during your treatment with VELSIPITY. Call your healthcare provider
right away if you have any of the following symptoms: blurriness or
shadows in the center of your vision, sensitivity to light, a blind
spot in the center of your vision, or unusually colored
vision.
- Types of skin cancer. Certain types of skin cancer have
happened with medicines in the same class as VELSIPITY. Limit the
amount of time you spend in sunlight and ultraviolet (UV) light
while taking VELSIPITY. Wear protective clothing and use a
sunscreen with a high sun protection factor. Tell your healthcare
provider if you have any changes in the appearance of your
skin.
- Swelling and narrowing of the blood vessels in your
brain. A condition called Posterior Reversible Encephalopathy
Syndrome (PRES) has happened with drugs in the same class. Symptoms
of PRES usually get better when you discontinue treatment. If not
treated, PRES may cause a stroke. Call your healthcare provider
right away if you have any of the following symptoms: sudden severe
headache, sudden confusion, sudden loss of vision or other changes
in your vision, or seizure. If you develop any of these symptoms,
your healthcare provider will stop treatment with VELSIPITY.
- Breathing problems. Some people who take medicines in
the same class as VELSIPITY may experience shortness of breath.
Your healthcare provider may do tests to check your breathing
during treatment with VELSIPITY. Call your healthcare provider
right away if you have new or worsening breathing problems.
The most common side effects of VELSIPITY include
headache, elevated liver tests, and dizziness. These are not all of
the possible side effects of VELSIPITY. For more information, ask
your healthcare provider or pharmacist. You may report side effects
to FDA at 1-800-FDA-1088. You may also report side effects to
Pfizer at 1-800-438-1985.
INDICATION
VELSIPITY is a prescription medicine used to treat adults with
moderately to severely active ulcerative colitis. It is not known
if VELSIPITY is safe and effective in children.
About Pfizer: 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 175 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 X at
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Disclosure Notice
The information contained in this release is as of February 19,
2024. 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
VELSIPITY (etrasimod), including its potential benefits, the grant
of a marketing authorization by the EC in the EU for VELSIPITY for
the treatment of patients 16 years of age and older with moderately
to severely active ulcerative colitis who have had an inadequate
response, lost response, or were intolerant to either conventional
therapy, or a biological agent, and applications pending for
VELSIPITY (etrasimod) in other jurisdictions, 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,
uncertainties regarding the commercial success of VELSIPITY
(etrasimod); 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 particular jurisdictions for VELSIPITY
(etrasimod) for any potential indications; whether and when any
applications that may be pending or filed for VELSIPITY (etrasimod)
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 VELSIPITY
(etrasimod) 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 VELSIPITY (etrasimod); uncertainties
regarding the impact of COVID-19 on Pfizer’s 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, 2022 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.
References:
- Ungaro R, et al. Ulcerative colitis. Lancet.
2017;389(10080):1756-70.
- Seyedian SS, et al. A review of the diagnosis, prevention, and
treatment methods of inflammatory bowel disease. J Med Life.
2019;12(2):113-122.
- Dubinsky MC, et al. Impact of Bowel Urgency on Quality of Life
and Clinical Outcomes in Patients With Ulcerative Colitis. Crohns
Colitis 360. 2022;4(3):otac016.
- Grimstad T, et al. Fatigue in Newly Diagnosed Inflammatory
Bowel Disease. J Crohns Colitis. 2015;9(9):7.
- Armuzzi A, et al. The Association between Disease Activity and
Patient-Reported Outcomes in Patients with Moderate-To-Severe
Ulcerative Colitis in the United States and Europe. BMC
Gastroenterol. 2020;20(1):18.
- Ordás I, et al. Ulcerative Colitis. Lancet.
2012;380(9853):1606-19.
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