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Lawsuit against Isis over Kynamro Safety Report Dismissed


A lawsuit filed against Isis Pharmaceuticals for allegedly misleading shareholders over claims made about the company's cholesterol-lowering antisense drug Kynamro, which was the subject of a troubling regulatory review, has been dismissed, Gene Silencing News has learned.

The lawsuit, which was filed on behalf of Isis shareholders, claimed that Isis and its management made “materially false and misleading statements regarding the safety and efficacy of the product, as well as reportedly positive results from Kynamro’s clinical trials” (GSN 1/3/2013).

In October, the US Food and Drug Administration published a clinical briefing document noting the incidence of abnormal growths or neoplasms in some patients treated with the drug, which had been submitted as a treatment for homozygous familial hypercholesterolemia. The report also found that three patients treated with Kynamro had died during clinical testing.

On the FDA report, shares of Isis tumbled nearly 22 percent.

Despite the report, the FDA last month approved Kynamro for the treatment of homozygous familial hypercholesterolemia (GSN 1/31/2013). And now, the litigation has been dismissed.

According to a court filing, the plaintiff has voluntarily agreed to drop the suit.