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familial hypercholesterolemia
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The European Committee for Medicinal Products for Human Use Has Adopted Positive Opinion
May 31, 2013The European Committee for Medicinal Products for Human Use (CHMP) has adopted positive opinion for Aegerion Pharmaceuticals' marketing authorization for Lojuxta (lomitapide) hard capsules. If approved, Lojuxta will be indicated for adult ...
Tags: Marketing Authorization, Medicine
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FDA Approval of Kynamro Injection Indicated for Homozygous Familial HoFH
Jan 31, 2013Genzyme and Isis have announced the FDA approval of Kynamro (mipomersen sodium) injection indicated for homozygous familial hypercholesterolemia (HoFH). The regulatory agency approved Kynamro 200mg subcutaneous injection per week as an ...
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Aegerion Has Received US FDA Approval to Be Used as an Adjunct to a Low-Fat Diet
Dec 28, 2012Aegerion Pharmaceuticals' Juxtapid (lomitapide) capsules has received US FDA approval to be used as an adjunct to a low-fat diet and other lipid-lowering treatments. Juxtapid, which is a supplement to fat reduction treatments also ...
Tags: Juxtapid, US, FDA, capsules, treatments
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Genzyme Submitted a New Drug Application to The FDA Seeking Approval for KYNAMRO
Dec 5, 2012Genzyme, a Sanofi company, has submitted a new drug application to the FDA seeking approval for KYNAMRO for the treatment of patients with homozygous familial hypercholesterolemia (HoFH). The submission is based on trial in which ...
Tags: KYNAMRO, homozygous familial hypercholesterolemia, HoFH
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REGENX Biosciences Has Received FDA Orphan Drug Designation
Apr 11, 2012REGENX BioSciences has received FDA orphan drug designation for treatment of familial hypercholesterolemia (HoFH) using NAV rAAV8 vectors. The REGENX program consists of a NAV rAAV8 vector expressing a normal copy of the human ...
Tags: orphan drug designation, familial hypercholesterolemia, clinical study
