To restrict access to therapy with KYNAMRO to patients with a clinical or laboratory diagnosis consistent with homozygousfamilialhypercholesterolemia (HoFH).
The vote was close, with 9 for approval and 6 against, and only for treatment in a rare genetic disease called homozygousfamilialhypercholesterolemia (HoFH).
The U.S. Food and Drug Administration today approved Kynamro (mipomersen sodium) injection as an addition to lipid-lowering medications and diet to treat patients with a rare type of high cholesterol called homozygousfamilialhypercholesterolemia (HoFH).