European Regulators Issue Negative Opinion on Isis DrugMonday, December 17, 2012
Isis Pharmaceuticals Inc.’s experimental cholesterol drug, Kynamro, recently failed to get approval from a European Union regulatory committee because of its likelihood to cause liver damage and other severe side effects in patients.
Carlsbad-based Isis has been developing Kynamro with Genzyme Corp. — a Massachusetts-based subsidiary of French drugmaker Sanofi — to treat patients with a rare form of high blood cholesterol called homozygous familial hypercholesterolemia, which can cause heart attacks at a young age.
The European panel, called the Committee for Medicinal Products for Human Use (CHMP), said that it “was of the opinion that the benefits of Kynamro did not outweigh its risks.”
The U.S. Food and Drug Administration, however, approved the medication in October, despite data also linking the drug to benign and cancerous tumors.
“We are disappointed with this opinion and the concerns expressed by the CHMP, but we are still optimistic that Kynamro will be approved in Europe,” said Isis chief executive Stanley Crooke in an investor call.
Despite the announcement, Isis’ stock price continues to rise, closing recently at $9.98, 37 cents up from the previous day.
— SDBJ Staff Report