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Kynamro Approval History

  • FDA approved: Yes (First approved January 29th, 2013)
  • Brand name: Kynamro
  • Generic name: mipomersen
  • Dosage form: Injection
  • Company: Genzyme and Isis Pharmaceuticals, Inc.
  • Treatment for: High Cholesterol, Familial Homozygous

Kynamro (mipomersen) is an oligonucleotide inhibitor of apolipoprotein B-100 synthesis indicated for the treatment of patients with homozygous familial hypercholesterolemia.

Development History and FDA Approval Process for Kynamro

Jan 30, 2013Approval FDA Approves New Orphan Drug Kynamro to Treat Inherited Cholesterol Disorder
Oct 19, 2012FDA Advisory Committee Recommends Kynamro for Homozygous Familial Hypercholesterolemia
May 29, 2012Genzyme and Isis Announce Filing of U.S. NDA for Kynamro (Mipomersen Sodium) in Homozygous Familial Hypercholesterolemia
Mar 29, 2012Genzyme and Isis Announce Submission of U.S. NDA for Kynamro (mipomersen sodium) in Homozygous Familial Hypercholesterolemia
Jan 11, 2011Isis Pharmaceuticals to Discuss Productive Regulatory Discussions Regarding the Mipomersen NDA Filing

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