LONDON (Reuters) – European regulators on Friday recommended against approval of Sanofi and Isis Pharmaceutical‘s drug Kynamro for treatment of a rare genetic disorder that causes unusually high cholesterol.
The European Medicines Agency said it was concerned about the medicine’s safety, noting that a high proportion of patients stopped taking it within two years, mainly due to side effects such as flu-like symptoms, injection site reactions and liver toxicity.
The European rebuff contrasts with a green light for the drug, known generically as mipomersen, by a U.S. advisory panel in October.
Sanofi’s Genzyme unit said it was disappointed by the decision and planned to request a re-examination.
(Reporting by Ben Hirschler)
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EU agency rejects Sanofi, Isis cholesterol drug
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EU agency rejects Sanofi, Isis cholesterol drug
