UCB Pharma, Inc., today announced that it filed
a supplemental new drug application (sNDA) with the U.S. Food and Drug
Administration (FDA) for a pediatric indication for the oral dosage forms
of its antiepileptic drug Keppra® (levetiracetam), as well as a new drug
application (NDA) for an intravenous form of Keppra®.
"These applications reflect the proven efficacy, ease of use and
tolerability of Keppra® for treating a variety of special populations,"
said Peter Verdru, M.D., senior medical director and head, Neurology,
Psychiatry and Clinical Development, UCB Pharma. The pediatric sNDA
proposes expanding the range of the indication to include children down to
four years of age. "A pediatric indication for Keppra® (levetiracetam)
will provide physicians with an important new add-on treatment option for
children with partial-onset seizures," said Dr. Verdru.
About 300,000 American children under the age of 14 have epilepsy(1). For
some, it will be a temporary problem, likely controlled with medication and
outgrown after a few years. For others, it may be a lifelong challenge
affecting many areas of life(2). Medications are usually the first-line
treatment for children with epilepsy.
UCB Pharma, Inc., also submitted a new drug application for an intravenous
form of Keppra® (levetiracetam) for adjunctive therapy in the treatment
of partial onset seizures in adults with epilepsy when oral administration
is temporarily not feasible. "An approval of Keppra® for intravenous
administration," Dr. Verdru noted, "will provide an important new add-on
option for treating partial seizures in a hospital setting."
The safety profile demonstrated in these clinical trials was similar to the
currently known safety profile of oral Keppra® in adults.
Keppra® is indicated as adjunctive therapy in the treatment of partial
onset seizures in adults with epilepsy. Keppra® is available in 250, 500
and 750 mg tablets and a grape-flavored (100 mg/mL) oral solution for
patients who prefer a solution or have difficulty swallowing tablets.
Taken with or without food, the effective recommended starting dose of
Keppra® is 1,000 mg/day given twice daily (500 mg bid). Since its
launch, Keppra® has had more than 500,000 unique patient starts in the
United States(3) and is the most prescribed second-generation AED used in
adults with epilepsy.(4)
Keppra® use is associated with the occurrence of central nervous system
adverse events, including somnolence and fatigue, coordination
difficulties, and behavioral abnormalities as well as hematological
abnormalities. Keppra® dosing must be individualized according to renal
function status. In well-controlled clinical studies, the most frequently
reported adverse events associated with the use of Keppra® in combination
with other AEDs, not seen at an equivalent frequency among placebo-treated
patients, were somnolence, asthenia, infection and dizziness.
Epilepsy is the most common neurological disorder, estimated to affect 50
million people worldwide(5) and 2.5 million Americans.(6) The disease can
strike at any time, but has the highest incidence in individuals under age
two and over 65. In the U.S., 181,000 new cases of epilepsy are diagnosed
each year. Up to 80 percent of people with epilepsy can gain full or
partial control of their seizures with treatments such as anti-epileptic
drugs.(7) Surgery, the ketogenic diet or an implanted device that delivers
electrical stimulation to the brain are other treatment options.
About UCB Pharma
UCB Pharma, Inc., with U.S. headquarters in Smyrna, Ga, is the North
American subsidiary of the global research-based pharmaceutical sector of
UCB S.A. The pharmaceutical sector is dedicated to the development and
commercialization of innovative pharmaceutical products for the treatment
of neurological diseases, allergy/immunology and oncology. UCB S.A. has
core businesses in pharmaceuticals and surface specialties, employs over
10,000 people globally, and operates in more than 100 countries. Worldwide
headquarters is located in Brussels, Belgium.
UCB Pharma, Inc.
Cell (404) 291-4772
Chandler Chicco Agency