ATLANTA, Sept. 15 /PRNewswire/ -- UCB today announced that its pivotal
Phase III monotherapy clinical trial had met its non-inferiority* primary
endpoint. This trial compared Keppra(R) (levetiracetam) to sustained release
carbamazepine in newly diagnosed patients, suffering from epilepsy with
partial or generalized tonic-clonic seizures. Keppra(R) demonstrated non-
inferiority to carbamazepine on seizure freedom. In addition the trial
provided further evidence of Keppra's favorable tolerability.
UCB plans to file a marketing authorization application with the European
Medicines Agency (EMEA) for the use of Keppra(R) as monotherapy in patients
with epilepsy and also plans to review the data with the US Food and Drug
Administration (FDA).
About Keppra(R)
In the US, Keppra(R) (levetiracetam) is indicated as adjunctive therapy in
the treatment of partial onset seizures in adults and children four years of
age and older with epilepsy. In adults, Keppra(R) 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. In pediatric patients 4 to 16 years of age,
Keppra(R) is associated with somnolence, fatigue, and behavioral
abnormalities, as well as hematological abnormalities. In adults, the most
common adverse events associated with Keppra(R) in combination with other AEDs
were somnolence, asthenia, infection, and dizziness. Of these, most appeared
to occur predominantly during the first 4 weeks of treatment. In pediatric
patients 4 to 16 years of age, the most common adverse events associated with
Keppra(R) in combination with other AEDs were somnolence, accidental injury,
hostility, nervousness, and asthenia. Please consult http://www.keppra.com for
US full prescribing information.
Note to Editors
* Non-inferiority
The EMEA's Committee for Medicinal Products for Human Use (CHMP) requires
demonstrating at least a similar benefit/risk balance of a test product as
compared to an acknowledged standard product at its optimal use, through the
conduct of a randomized, double-blind, non-inferiority trial.
Optimal use of the comparator implies:
-- patients with primary generalized seizures were excluded from the trial
-- a low-initial target dose and a slow titration regimen were applied
-- carbamazepine's sustained release formulation was used.
About UCB
UCB (http://www.ucb-group.com) is a global biopharmaceutical leader
dedicated to the research, development and commercialization of innovative
products in the fields of central nervous system disorders, allergy and
respiratory diseases, immune and inflammatory disorders and oncology. UCB
employs over 8,500 people operating in over 40 countries, and achieved
revenues of euro 2.1 billion (including net turnover, royalties, and fees) in
2004. UCB is listed on the Euronext Brussels. Worldwide headquarters are
located in Brussels, Belgium.
UCB Pharma, Inc. is the North American subsidiary of UCB, with U.S.
headquarters located in Smyrna, Georgia. UCB's key products in the U.S. are
Keppra(R) (levetiracetam), Zyrtec(R)(1) (cetirizine HCl), Tussionex(R) CIII
(hydrocodone polistirex/chlorpheniramine polistirex), and Metadate(R) CD CII
(methylphenidate HCl, USP).
(1) Zyrtec is licensed to and co-promoted with Pfizer, Inc. in the United
States.
SOURCE UCB Pharma, Inc.
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Related links:
http://www.keppra.com
http://www.ucb-group.com
CONTACT:
U.S. Contact: Lisa Garman, of UCB Pharma,
Inc., +1-770-970-8569, lisa.garman@ucb-group.com
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