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EMA recommends approval for Sanofi vaccine Hexyon
25-February-2013: The latest set of opinions from the European Medicines Agency includes a recommendation for Sanofi's six-in-one paediatric vaccine.
The agency's Committee for Medicinal Products for Human Use has issued a positive opinion for the French drugmaker's Sanofi Pasteur unit's Hexyon/Hexacima. The company says that it is the only fully liquid, ready-to-use, six-in-one vaccine to protect infants against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive infections caused by Haemophilus influenzae type b.
When finally approved, the new vaccine will be sold as Hexyon in western European countries by the firm's joint venture with Merck Sharp and Dohme - Sanofi Pasteur MSD - and under the brand name Hexacima in eastern European by the French company. Olivier Charmeil, chief executive of Sanofi Pasteur, said the therapy "will raise the standard of care of vaccination for millions of children".
The CHMP also backed French firm Lucane Pharma's Pheburane for the treatment of chronic management of urea-cycle disorders. It also recommended expanded use of GlaxoSmithKline's human papillomavirus vaccine Cervarix and CSL Behring's intravenous immunoglobulin therapy Privigen.
The agency also issued positive recommendations for generics of Lundbeck's Alzheimer's disease drug Ebixa from Mylan and Actavis