U.S. pharmaceutical company Genzyme, a unit of French group
Sanofi SA (SAN.FR), and Isis Pharmaceuticals Inc. (ISIS) Friday
said the Committee for Medicinal Products for Human Use of the
European Medicines Agency, the body that authorizes drugs in the
European Union, issued a negative opinion for Kynamro, a drug
treating homzygous familial hypercholesterolaemia.
MAIN FACTS:
- Genzyme plans to request a re-examination of the negative
opinion.
- Genzyme and Isis said an application of Kynamro is currently
under review by the U.S. Food and Drug Administration.
- The companies said Kynamro received in October 2012 a positive
vote by the FDA advisory panel, which had said the company had
provided sufficient efficacy and safety data to support the
marketing of the drug for the treatment of patients with homozygous
familial hypercholesterolemia
-Write to Inti Landauro at inti.landauro@dowjones.com
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