|[October 28, 2013]
Lundbeck's SABRIL® (vigabatrin) Now Approved by U.S. FDA as an Adjunctive Treatment Option for Children 10 and older with Refractory Complex Partial Seizures
DEERFIELD, Ill. --(Business Wire)--
The U.S. Food and Drug Administration (FDA) approved SABRIL (vigabatrin)
as add-on therapy for the treatment of refractory complex partial
seizures (CPS) in children 10 years of age and older who have
inadequately responded to several other treatments and if the possible
benefit outweighs the risk of vision loss.1 This approval
expands upon the age range of SABRIL's previous indication as adjunctive
therapy for adults with refractory CPS. SABRIL is not indicated as a
first-line agent for refractory CPS.
Of the more than two million Americans affected by epilepsy,2
approximately 35 percent have CPS, which originates from a single region
of the brain and can cause impaired consciousness.3
Approximately 30 to 36 percent of those with CPS continue to have
seizures despite trying multiple therapies, and are considered to have
"It is crucially important for people with challenging seizures like
refractory CPS to not give up and continue striving for improved seizure
management, and this expanded Sabril indication provides another
consideration for the treatment of those ten and older with refractory
CPS," said Philip Gattone, president and CEO of the Epilepsy Foundation.
"We encourage people living with such challenging seizures and their
loved ones to have ongoing conversations with their doctor about
available options to help manage this intractable seizure disorder."
When SABRIL was first approved in 2009, a patient registry was
established to collect information on all patients who are prescribed
SABRIL. To date, more than 5,600 patients have been treated with SABRIL,
a substantial number of whom have been treated for refractory CPS.7
In evaluating whether to start SABRIL, doctors, patients and their
caregivers work together to assess the risk of permanent vision loss
versus the benefit of seizure reduction. There are other serious risks
associated with SABRIL. Please see the important safety information
below for more details.
"With so many children still having seizures due to refractory CPS, we
are very pleased that the FDA has approved SABRIL for patients 10 and
older who may benefit from a new add-on treatment option," said Amy
Magro, Director of Epilepsy Marketing at Lundbeck. "For those caring for
a child as young as 10, we hope this new indication provides
encouragement to speak with their child's doctor about the risks and
potential benefits of adding SABRIL for refractory CPS."
In addition to its refractory CPS indication, SABRIL is approved for use
in babies one month to two years of age with infantile spasms if the
possible benefit outweighs the potential risk of vision loss.
For more information, please visit www.SABRIL.net.
About SABRIL® (vigabatrin)1
SABRIL is a prescription oral antiepileptic drug developed in the United
States by Lundbeck. SABRIL is available in 500-mg tablets or 500-mg
packets of powder for oral suspension. Because of the risk of permanent
vision loss, SABRIL is available only through a restricted program under
a REMS called the SHARE Program. (1-888-45-SHARE).
SABRIL (vigabatrin) is a prescription medicine used with other
treatments in adults and children 10 years of age and older with
refractory complex partial seizures (CPS), who have not responded well
enough to several other treatments, and if the possible benefits
outweigh the risk of vision loss. SABRIL should not be the first
medicine used to treat CPS.
SABRIL (vigabatrin) is a prescription medicine used in babies, 1 month
to 2 years old, with infantile spasms (IS), if the possible benefits
outweigh the possible risk of vision loss.
Important Safety Information
WARNING: VISION LOSS
See Medication Guide and full Prescribing Information for complete
In all people who take SABRIL:
You are at risk for vision loss with any amount of SABRIL
Your risk of vision loss may be higher the more SABRIL you take
daily and the longer you take it
It is not possible for your healthcare provider to know when vision
loss will happen. It could happen soon after starting SABRIL or any
time during treatment. It may even happen after treatment has stopped.
SABRIL can permanently damage the vision of anyone who takes it.
The most noticeable loss is in the ability to see to the side when
looking straight ahead (peripheral vision). If this happens, it will
not get better. People who take SABRIL do not lose all of their
vision, but some people can have severe loss and may only be able to
see things straight in front of them (sometimes called "tunnel
vision"), and they may also have blurry vision.
Tell your healthcare provider right away if you (or your child):
might not be seeing as well as before starting SABRIL; start to trip,
bump into things, or are mre clumsy than usual; are surprised by
people or things coming in front of you that seem to come out of
nowhere; or if your baby is acting differently than normal. These
changes can mean that vision damage has occurred.
Your healthcare provider will test your (or your child's) vision
before or within 4 weeks after starting SABRIL, and at least every 3
months during treatment until SABRIL is stopped. Vision should also be
tested about 3 to 6 months after SABRIL is stopped. You (or your
child) may not be able to be tested in certain situations. It is
difficult to test vision in babies, but to the extent possible, all
babies should have their vision tested. Your healthcare provider will
determine if testing can be done. Regular vision testing is important
because damage can happen before any changes are noticed.
Vision tests cannot prevent the vision damage that can happen with
SABRIL, but they do allow SABRIL to be stopped if vision has gotten
worse, which usually will lessen further damage. Even these regular
vision tests may not show vision damage before it is serious and
permanent. Parents, caregivers, and healthcare providers may not
recognize the symptoms, or find vision loss in babies, until it is
If vision tests are not done regularly, your healthcare provider
may stop prescribing SABRIL for you (or your child). Some people are
not able to complete vision testing. If vision testing cannot be done,
your healthcare provider may continue prescribing SABRIL, but will not
be able to watch for any vision loss.
Brain pictures taken by magnetic resonance imaging (MRI) show changes
in some babies after they are given SABRIL. It is not known if these
changes are harmful.
Like other antiepileptic drugs, SABRIL may cause suicidal thoughts and
actions in some people. Call a healthcare provider right away if you
(or your child) have any symptoms, especially sudden changes in mood,
behaviors, thoughts or feelings, and especially if they are new,
worse, or worry you.
Do not stop SABRIL without first talking to a healthcare provider.
Stopping SABRIL suddenly can cause seizures that will not stop.
SABRIL can cause serious side effects such as low red blood cell
counts, sleepiness and tiredness, nerve problems, weight gain, and
edema. Because SABRIL causes sleepiness and tiredness, do not drive,
operate machinery, or perform hazardous tasks, unless it is decided
that these things can be done safely. SABRIL may make certain types of
seizures worse. Tell your healthcare provider right away if seizures
Before starting SABRIL, tell your doctor about all of your (or your
child's) medical conditions including depression, mood problems,
suicidal thoughts or behavior, any allergic reaction to SABRIL, vision
problems, kidney problems, low red blood cell counts, and any nervous
or mental illness. Tell your doctor about all the medicines you (or
your child) take.
If you are breastfeeding or plan to breastfeed, SABRIL can pass into
breast milk and may harm your baby. If you are pregnant or plan to
become pregnant, it is not known if SABRIL will harm your unborn baby.
You and your healthcare provider will have to decide if you should
take SABRIL while you are pregnant.
The most common side effects of SABRIL in adults include: problems
walking or feeling uncoordinated, feeling dizzy, shaking (tremor),
joint pain, memory problems and not thinking clearly, eye problems
like blurry vision, double vision, and eye movements that cannot be
controlled. The most common side effects of SABRIL in children 10 to
16 years of age include weight gain, upper respiratory tract
infection, tiredness, and aggression. Also expect side effects like
those seen in adults.
The most common side effects of SABRIL in babies include:
sleepiness-some babies may have a harder time suckling and feeding or
may be irritable, swelling in the bronchial tubes (bronchitis), ear
infection, and irritability.
Tell your healthcare provider if you or your child has any side effect
that bothers you or that does not go away. These are not all of the
possible side effects of SABRIL. For more information, ask your
healthcare provider or pharmacist.
Please see SABRIL Medication
Prescribing Information including Boxed Warning, and Instructions
for Use; go to www.sabril.net,
or call toll-free 1-888-45-SHARE (1-888-457-4273).
You are encouraged to report negative side effects of prescription
drugs to the FDA. Visit www.fda.gov/medwatch,
or call 1-800-FDA-1088.
About Lundbeck in the U.S.
A wholly owned subsidiary of H. Lundbeck A/S of Denmark, Lundbeck in the
United States is headquartered in Deerfield, Illinois, and is committed
to providing innovative specialty therapies that fulfill unmet medical
needs of people with central nervous system (CNS) disorders, including
several therapies for people with challenging seizure disorders.
With a special commitment to the epilepsy community, Lundbeck actively
supports and participates in hundreds of community-based initiatives.
Learn more about our epilepsy community programs at http://www.lundbeck.com/us/our-commitment/community-involvement.
About H. Lundbeck A/S
Lundbeck is a global pharmaceutical company highly committed to
improving the quality of life of people living with brain diseases. For
this purpose, Lundbeck is engaged in the entire value chain throughout
research, development, production, marketing and sales of
pharmaceuticals across the world. The company's products are targeted at
disorders such as depression and anxiety, psychotic disorders, epilepsy,
Huntington's, Alzheimer's and Parkinson's diseases. Lundbeck's pipeline
consists of several mid- to late-stage development programs.
Lundbeck employs more than 5,800 people worldwide, 2,000 of whom are
based in Denmark. We have employees in 57 countries and our products are
registered in more than 100 countries. We have research centers in
Denmark, China and the United States and production facilities in Italy,
France, Mexico, China and Denmark. Lundbeck generated revenue of
approximately DKK 15 billion in 2012. Lundbeck's shares are listed on
the stock exchange in Copenhagen under the symbol "LUN." Lundbeck has a
sponsored Level 1 ADR programme listed in the US (OTC) under the symbol
"HLUYY." For additional information, we encourage you to visit our
corporate site www.lundbeck.com.
1. SABRIL® (vigabatrin) full Prescribing Information, Deerfield, IL.
2. Epilepsy Foundation. About Epilepsy: Statistics. http://www.epilepsyfoundation.org/aboutepilepsy/index.cfm/statistics.
3. Carroll E. Medscape. Complex Partial Seizures. http://emedicine.medscape.com/article/1183962-overview.
4. Kwan P, Brodie MJ. Early identification of refractory epilepsy. N
Engl J Med. 2000; 342:314-9.
5. Devinsky O. Patients with refractory seizures. N Engl J Med.
6. Rielo DM. Medscape. Vagus Nerve Stimulation. 2011. http://emedicine.medscape.com/article/1186123-overview.
7. Data on File.
SABRIL is a registered trademark of Lundbeck.
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