The US Food and Drug Administration (FDA) recently approved
) Juxtapid (lomitapide) capsules. Juxtapid has been approved for
the treatment of patients suffering from homozygous familial
hypercholesterolemia (HoFH) as an adjunct to a low-fat diet and
other lipid-lowering therapies.
The FDA's decision was based on positive results from a phase
III study on Juxtapid. Aegerion evaluated the safety and
effectiveness of the drug in reducing low-density lipoprotein
cholesterol (LDL-C) levels in 29 adults suffering from HoFH, in
Results from the study revealed that Juxtapid when added to
existing lipid-lowering therapy resulted in a 40% reduction in
LDL-C in HoFH patients who discontinued the study prematurely at
week 26. The same was reduced by 50% in 23 patients who completed
the study through week 26.
We note that Juxtapid's label carries a boxed warning
regarding the risk of liver toxicity. The drug is available
through the Juxtapid Risk Evaluation and Mitigation Strategy
(REMS) Program due to the risk of liver toxicity.
Aegerion will be conducting an observational cohort study on
the drug for the long-term safety and effectiveness of the drug,
as per its commitment to the FDA.
We are encouraged with the approval of Juxtapid. We note that
) are also looking to enter the market with their HoFH candidate,
Kynamro, which is currently under review in the US.
We currently have a Neutral recommendation on Aegerion. The
stock carries a Zacks #3 Rank (Hold). Other stocks in the pharma
sector that carry a Zacks #1 Rank (Strong Buy) are
AEGERION PHARMA (AEGR): Free Stock Analysis
ISIS PHARMACEUT (ISIS): Free Stock Analysis
REPLIGEN (RGEN): Free Stock Analysis Report
SANOFI-AVENTIS (SNY): Free Stock Analysis
TARGACEPT INC (TRGT): Free Stock Analysis
To read this article on Zacks.com click here.