EU Agency Rejects Sanofi, Isis Cholesterol Drug
European regulators recommended against approval of Sanofi and Isis Pharmaceutical's Kynamro drug 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.
A Sanofi spokeswoman said the company expected feedback from the regulator in the second quarter of 2013.
Isis founder and Chief Executive Stanley Crooke said on a conference call with analysts he was still optimistic on securing approvals in both the United States and Europe.
"Even though I cannot address the specific concerns of the (EU) committee ... I can say that each issue raised by the (committee) was thoroughly reviewed by the FDA," Crooke said. "We do not believe that today's opinion should have a negative impact elsewhere."
California-based Isis is entitled to 30% of total sales of Kynamro once the drug reaches the market, rising to 50% for sales over $2 billion.
