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news.Genzyme and Isis Pharmaceutical have filed marketing authorization application (MAA) asking approval for 200mg weekly dose of mipomersen as a treatment of homozygous and severe heterozygous familial hypercholesterolemia with the European Medicines Agency (EMA).
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Currently, mipomersen is in late-stage development for the reduction of LDL cholesterol (LDL-C).
Genzyme and Isis Pharma said that if approved the drug will be marketed under Kynamro brand name.
Genzyme’s vice president, Cardiovascular Business general manager Paula Soteropoulos said they look forward to their upcoming US regulatory submission later this year.
Isis Pharma chairman and CEO Stanley Crooke said Mipomersen has the potential to change the management of patients with homozygous and severe heterozygous familial hypercholesterolemia.