Avanir Pharma Reveals Positive CHMP Opinion For NUEDEXTA Approval In Europe
WASHINGTON (dpa-AFX) - Avanir Pharmaceuticals Inc. (AVNR) said the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency or EMA has adopted a positive opinion for NUEDEXTA, recommending NUEDEXTA be approved to treat pseudobulbar affect or PBA, irrespective of neurologic cause. Further, the CHMP recommended approval of two dose strengths of NUEDEXTA; 20/10 mg and 30/10 mg capsules.
PBA is a neurologic condition characterized by outbursts of uncontrollable crying or laughing that are often contrary or exaggerated to the patient's inner mood state.
The European Commission, which is authorized to approve medicines for use in the European Union, follows the recommendations of the CHMP and typically renders a final decision within three months of the CHMP opinion. If the CHMP recommendation is formally adopted by the European Commission, NUEDEXTA would be approved for marketing in all 27 member states of the European Union plus Iceland and Norway.
Joao Siffert, chief scientific officer of Avanir noted, 'We will continue to work with the European Medicines Agency and the European Commission toward the marketing authorization so that patients suffering from PBA have ready access to NUEDEXTA in Europe.'
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