FDA grants marketing approval for Lundbeck's Sabril® (vigabatrin)
- First FDA-approved treatment for infantile spasms
- New adjunctive treatment for adults with refractory complex
H. Lundbeck A/S today announced that the US Food and Drug
Administration (FDA) has granted two New Drug Application (NDA)
approvals for Sabril® (vigabatrin) Tablets and Oral Solution.
Lundbeck Inc. plans to launch Sabril in the US during the third
quarter of 2009, with an extensive Risk Evaluation and Mitigation
Strategy (REMS) program as required by the FDA and created in
collaboration with the agency.
Sabril is the first therapy approved by the FDA for the treatment of
infantile spasms (IS) and an important new adjunctive therapeutic
option for the approximately 30 to 36 percent of adults with complex
partial seizures (CPS) whose seizures remain uncontrolled in spite of
having many antiepileptic therapies already available[i] [ii].
Sabril is indicated as monotherapy for paediatric patients one month
to two years of age with IS for whom the potential benefits outweigh
the potential risk of vision loss. IS is characterized by spasms that
may occur in clusters of up to 100 at a time. Sabril represents the
only treatment approved by the FDA to help manage this
Sabril is also indicated as adjunctive therapy for adult patients
with refractory CPS who have inadequately responded to several
alternative treatments and for whom the potential benefits outweigh
the risk of vision loss. Sabril is not indicated as a first-line
agent for CPS. This patient group is inherently difficult to treat
and is in need of additional treatment alternatives to help reduce
the number of seizures.
Commenting on the approval of the lead compound in its CNS pipeline,
Ulf Wiinberg, President and CEO at Lundbeck said, "Infantile spasms
and refractory complex partial seizures in adults are
difficult-to-treat epilepsies and we are pleased to be able to
address the unmet medical need patients with infantile spasms have
faced and to offer an additional choice in treating refractory
complex partial seizures. FDA approval of Sabril is an important step
forward for the entire epilepsy community and provides patients with
a new treatment option that could reduce seizures among these adult
patients and may eliminate spasms in a certain proportion of children
with infantile spasms."
Lundbeck has together with the FDA established a comprehensive REMS
to manage the risk of permanent vision loss associated with the
product. The Sabril REMS, which was a critical component in receiving
FDA approval, specifies elements, such as restricted product
distribution, required vision testing and mandatory risk-benefit
assessments, to manage the risk of vision loss associated with
Sabril. Like all other antiepileptic drugs, the REMS also addresses
the risk for suicidality associated with the class.
The Sabril REMS is administered through Lundbeck's SHARE (Support,
Help and Resources for Epilepsy) program, a comprehensive patient and
physician support program designed to provide tools and resources for
all of Lundbeck's epilepsy products, including Sabril. Through SHARE
and the recently established SHARE Call Center, patients, caregivers
and physicians will have access to information and tools to help
manage severe and uncontrolled epilepsy, programs to help facilitate
initial and ongoing use of Sabril and support from a team dedicated
to helping people fully understand and navigate the Sabril
Sabril causes permanent vision loss in infants, children and adults.
Sabril-induced vision loss includes progressive and permanent
bilateral concentric visual field constriction in 30 percent or more
of patients on the therapy that ranges in severity from mild to
severe, including tunnel vision to within 10 degrees of visual
fixation, and can result in disability. There are also some reports
that Sabril can damage the central retina and decrease visual acuity.
The onset is unpredictable and can occur within weeks of starting
treatment, or sooner, or at anytime during treatment even after
months or years.
The content of this release will have no influence on the Lundbeck
Group's financial result for 2009.
Lundbeck made an upfront payment of USD 600 million (or approximately
DKK 3.5 billion) immediately upon closing of the acquisition of
Ovation Pharmaceuticals, Inc. An additional payment of USD 300
million (or approximately DKK 1.6 billion) will now be paid in
connection with the approval of Sabril by the FDA.
About complex partial seizures
There are three million Americans affected by epilepsy[iii] and
approximately 35 percent have CPS, the single largest seizure type,
which originates from a single region of the brain and can cause
impaired consciousness[iv]. Despite the availability of more than 20
antiepileptic drugs, approximately 30 to 36 percent of adults with
CPS continue to have uncontrolled seizures[v]. Sabril provides a new
and valuable adjunctive treatment option for adult CPS patients who
have not responded to several alternative treatments and are
considered 'refractory' to treatment. Given the potential benefit
compared to the risk of permanent vision loss, it is expected that
only a small percentage of refractory CPS patients will initiate and
maintain treatment with Sabril as adjunctive therapy.
About infantile spasms
Infantile spasms is a difficult-to-treat epilepsy syndrome that
usually strikes infants between three to six months old[vi]. An
estimated 8,500 infants in the US have been diagnosed with IS[vii].
Each year, approximately 2,500 new cases of IS are reported in the US
and until now, no FDA-approved treatments have been available. Sabril
may not be appropriate for use in all IS patients given the potential
risk of permanent vision loss.
About Sabril® (vigabatrin) Tablets and Oral Solution
Sabril is an oral antiepileptic drug developed in the US by Lundbeck
Inc. Sabril is available in two formulations - in 500 mg tablets for
use as adjunctive therapy for adults with refractory CPS and in 500
mg packets of powder for oral solution for infants with IS. The
precise mechanism of Sabril's anti-seizure effect is unknown, but is
believed to be the result of its action as an irreversible inhibitor
of gamma-aminobutyric acid transaminase (GABA-T), the enzyme
responsible for the metabolism of the inhibitory neurotransmitter
GABA. This action results in increased levels of GABA in the central
nervous system. No direct correlation between plasma concentration
and efficacy has been established. The duration of drug effect is
presumed to be dependent on the rate of enzyme resynthesis rather
than on the rate of elimination of the drug from the systemic
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Investor Relations Officer
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H. Lundbeck A/S (LUN.CO, LUN DC, HLUKY) is an international
pharmaceutical company highly committed to improve the quality of
life for people suffering from central nervous system (CNS)
disorders. For this purpose Lundbeck is engaged in the research and
development, production, marketing and sale of pharmaceuticals across
the world, targeted at disorders like depression and anxiety,
schizophrenia, insomnia, Huntington's, Alzheimer's and Parkinson's
Lundbeck was founded in 1915 by Hans Lundbeck in Copenhagen, Denmark,
and employs today over 5,500 people worldwide. Lundbeck is one of the
world's leading pharmaceutical companies working with CNS disorders.
In 2008, the company's revenue was DKK 11.3 billion (approximately
EUR 1.5 billion or USD 2.2 billion). For more information, please
[i] Kwan P, Brodie MJ. Early identification of refractory epilepsy.
New England Journal of Medicine. February 3, 2000;342:314-319.
[ii] Devinsky O. Patients with refractory seizures. New England
Journal of Medicine. May 20, 1999; 340:1565-70.
[iii] Epilepsy and Seizure Statistics. Epilepsy Foundation.org.
http://www.epilepsyfoundation.org/about/statistics.cfm. Last accessed
[iv] Murro, Anthony M. EMedicine.com. Complex Partial Seizures.
http://www.emedicine.com/Neuro/topic74.htm Last accessed on
February 17, 2009.
[v] Sperling, M. The consequences of uncontrolled epilepsy. CNS
[vi] National Institute of Neurological Disorders and Stroke. NINDS
Infantile Spasms Information Page. Available at:
Last accessed on December 8, 2008.
[vii] Hurst D. The epidemiology of infantile spasms. In: Dulac O,
Chugani H. Dalla Bernardina B., eds. Infantile Spasms and West
Syndrome. Philadelphia, PA: Saunders; 1994.
[viii] Sabril® (vigabatrin) for Oral Solution full Prescribing
Information, including Boxed Warning