Genzyme and Isis Announce Submission of European Marketing Authorization Application for Mipomersen (Kynamro)

Submission Seeks Approval for Mipomersen’s Use in the Treatment of Homozygous Familial Hypercholesterolemia and Severe Heterozygous Familial Hypercholesterolemia

01-Aug-2011 - USA

Genzyme, a Sanofi company, and Isis Pharmaceuticals Inc. announced that Genzyme has submitted a marketing authorization application (MAA) to the European Medicines Agency seeking approval for the 200 mg weekly dose of mipomersen for the treatment of homozygous and severe heterozygous familial hypercholesterolemia.

“We also look forward to our upcoming U.S. regulatory submission later this year, as these submissions move us closer to our goal of making mipomersen available to patients who are in the greatest need of new treatments.”

“This MAA submission is another significant step in the development of mipomersen,” said Vice President and General Manager of Genzyme’s Cardiovascular Business, Paula Soteropoulos. “We also look forward to our upcoming U.S. regulatory submission later this year, as these submissions move us closer to our goal of making mipomersen available to patients who are in the greatest need of new treatments.”

Genzyme and Isis also announced today that, if the necessary approvals are granted, mipomersen would be marketed under the brand name Kynamro®, the registered name that has been submitted to health authorities for the investigational agent.

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