EU agency rejects Sanofi, Isis cholesterol drug

LONDON Fri Dec 14, 2012 7:52am EST

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)