UCB Receives EMEA Positive Opinion and FDA Approvable Letter for Keppra® (levetiracetam) Intravenous Administration
Brussels, BELGIUM, February 3, 2006: UCB today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has issued a positive opinion to approve marketing authorisation of Keppra® (levetiracetam) Concentrate (100 mg/mL) as an intravenous administration and for use as adjunctive therapy in the treatment of partial onset seizures with or without secondary generalisation in adults and children of four years of age and older with epilepsy.
UCB also received an approvable letter from the U.S. Food and Drug Administration (FDA) in response to the New Drug Application (NDA) for Keppra® (levetiracetam) Injection 100 mg/mL for use as adjunctive therapy in the treatment of partial onset seizures in adult patients with epilepsy. In the approvable letter, the FDA has requested revised product labelling as well as some additional information regarding manufacturing to finalize its review. UCB has already submitted the requested information to the FDA.
"This positive news is an important step in the continuing development of Keppra®." said Roch Doliveux, Chief Executive Officer. "This new Keppra® formulation will be of help to patients and physicians in emergency seizure situations where oral medication is not an option. When approved by the regulatory authorities, Keppra® will become the first of the newer antiepileptic drugs to be available in an intravenous formulation."
Keppra® is currently approved in the U.S. in tablet and oral solution formulations for adjunctive therapy in the treatment of partial onset seizures in adults and children four years of age and older with epilepsy. In Europe, Keppra® is approved in tablet and oral solution formulations for adjunctive therapy in the treatment of partial onset seizures with or without secondary generalisation in adults and children four years of age and older with epilepsy. In adults, the use of Keppra® is associated with the occurrence of central nervous system adverse events including somnolence and fatigue, coordination difficulties, and behavioural abnormalities, as well as hematological abnormalities. In paediatric patients 4 to 16 years of age, Keppra® is associated with somnolence, fatigue and behavioural abnormalities, as well as hematological abnormalities. In adults, the most common adverse events associated with Keppra® in combination with other AEDs are somnolence, asthenia, infection, and dizziness. Of these, most appeared to occur predominantly during the first 4 weeks of treatment. In paediatric patients the most common adverse events associated with Keppra® in combination with other AEDs are somnolence, accidental injury, hostility, nervousness, and asthenia. Please consult local prescribing information. For the U.S. prescribing information is available at www.keppra.com.
UCB (www.ucb-group.com) is a global biopharmaceutical leader with headquarters in Brussels, Belgium, specialising in the fields of central nervous system disorders, inflammatory diseases, and oncology. UCB key products are Keppra® (levetiracetam), Zyrtec®* (cetirizine HCl), Tussionex® CIII (hydrocodone polistirex/chlorpheniramine polistirex), and Equasym(TM)/Metadate CD(TM) CII (methylphenidate HCl, USP). UCB employs 8,500 people operating in over 40 countries. UCB is listed on Euronext Brussels (UCB / UCBBt.BR / UCB BB).
*Zyrtec® is licensed to and co-promoted with Pfizer, Inc. in the U.S.
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