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  • 平井 将秀


From Associated Press (January 30, 2013)


Drug developer Isis Pharmaceuticals Inc. and partner Genzyme announced Tuesday that the U.S. Food and Drug Administration has approved their new drug application for Kynamro, clearing the way for Isis’first drug to reach market.

薬剤開発企業のアイシスファーマシューティカル社(Isis Pharmaceutical)とその提携企業のジェンザイム社は火曜、食品医薬品局が「Kynamro」の新薬申請を承認したと発表しました。これによりアイシス社初の医薬品が市場に出回ることになります。

Kynamro is an injectable drug designed to treat patients who are genetically predisposed to have high levels of LDL cholesterol. The drug has been approved for use as an adjunct to lipid-lowering medications and diet for patients with homozygous familial hypercholesterolemia.


HoFH is a rare inherited condition that makes the body unable to remove LDL cholesterol from the blood, causing abnormally high levels of circulating LDL cholesterol. In the United States, HoFH occurs in about one in one million individuals, according to the company.


Approval of the drug was not certain in the past. There were questions about its links to cancer. But the companies said in October that an advisory panel to the FDA decided there was sufficient data on the drug’s safety and effectiveness to allow sales of Kynamro.

The companies said Tuesday that the drug may cause serious side effects, including liver problems.


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