SK Biopharmaceuticals, a South Korean pharmaceutical company, announced
today that it was granted special status by the U.S. Food and Drug
Administration (FDA) for carisbamate for the management of patients with
infantile spasms (IS), a form of epilepsy associated with increased risk
of death or mental retardation.
Dr. Christopher Gallen, CEO of SK Biopharmaceuticals, said, "Carisbamate
is an important new anti-seizure therapy. Experimental evidence
demonstrates its utility in a model of IS. The designation of
carisbamate as an Orphan Drug by the FDA facilitates our progression of
this vital medication to yet another area of great unmet medical need."
The FDA grants Orphan Drug designation to products that are intended to
treat rare or orphan diseases or conditions such as infantile spasms.
For IS patients, as with patients fighting other rare diseases, new
treatments are few and far between, making this designation by the FDA
of significant importance.
"IS, or West Syndrome, is a devastating and difficult to treat form of
childhood epilepsy that often leads to some form of mental retardation
and other behavioral problems over time," said Dr. Jeongwoo Cho, Vice
President of SK Biopharmaceuticals' Drug Development Business.
"Carisbamate is being developed to provide physicians with an additional
treatment option for patients with IS for whom there are very few safe
and effective treatments."
Carisbamate has been designated as an orphan drug by the FDA under the
auspices of the Orphan Drug Act. The Act, which will mark its 30th
anniversary on January 4, 2013, provides incentives to sponsors that
develop therapies intended to treat orphan conditions, which are
classified as any condition or disease that affects less than 200,000
patients per year in the U.S. It is estimated that there are more than
6,000 rare diseases affecting 25 million Americans.
Carisbamate has previously been shown to have efficacy in clinical
trials for adult forms of epilepsy, such as partial onset seizures.
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