Europe gives thumbs down to Sanofi's cholesterol drug mipomersen

Although recently approved by the FDA, Europe's Committee for Medicinal Products for Human Use has decided not to recommend approval for Isis ($ISIS) and Sanofi's ($SNY) cholesterol-lowering drug mipomersen. CHMP said it reaffirmed its position to not recommend mipomersen for approval because its earlier apprehension about the drug remains unresolved. Some patients in Europe--those in clinical trials or in compassionate-use programs--will still be able to receive the drug. CHMP cited two major concerns: the fact that a high proportion of patients had stopped taking the medicine within two years and the potential for long-term consequences of fat buildup in the liver and increased enzyme levels. More

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