MINYANVILLE ORIGINAL A rare genetic condition that causes heart attacks at a young age is getting a lot of attention this week as rival companies tout a pair of experimental drugs aimed at treating the disease.
(NASDAQ:AEGR) will appear before a panel of government advisers Wednesday to discuss its oral treatment lomitapide for homozygous familial hypercholesterolemia
, a condition characterized by very high levels of bad cholesterol. The drug has a risk of liver damage, but comments made by Food and Drug Administration staff in a report
prior to Wednesday’s meeting cheered investors who have bid up the stock 15% in two days. A positive recommendation by the advisers may bode well for possible FDA approval, which explains the rise in the stock.
(NASDAQ:ISIS) and partner Sanofi
(NYSE:SNY) are also developing a treatment for the genetic condition, the injected drug mipomersen sodium. But some investors aren’t so confident that this drug, branded Kynamro, is on the path to approval. Shares of Isis fell 19% Tuesday after another FDA staff report
noting safety concerns of Kynamro, including risk of possible tumor growth. Isis and Sanofi’s Genzyme face an FDA panel on Thursday.
Isis traded at $10.69 midday Tuesday. The shares are still up 48% this year. Aegerion’s stock was $18.25 midday. Those shares are up more than 40% over the past six months. The US shares of Paris-based Sanofi rose 3% to $45.13 Tuesday.
The reports prepared for the panels are used to guide discussion among the advisers. The panelists will vote on the merits of both drugs, sending their recommendations to the FDA, which considers the advice as part of the approval process. The FDA isn’t bound by any recommendation made. In fact, the agency sometimes goes against the advice of a panel. But if the experts are overly concerned about safety issues of particular drugs, there’s a good chance the FDA will not approve a drug.
The FDA is expected to rule on Aegerion’s drug by the end of the year and on the Isis-Sanofi treatment in January. Currently, the most common treatment for patients with homozygous familial hypercholesterolemia are cholesterol-lowering statins such as Pfizer’s
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