FDA Gives New Drug Application Approval to Isis
From Associated Press (January 30,
CARLSBAD, Calif. -- 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.
Kynamro is an injectable drug
designed to treat patients who are genetically predisposed to have
high levels of LDL cholesterol, known as the "bad" cholesterol. The
drug has been approved for use as an adjunct to lipid-lowering
medications and diet for patients with homozygous familial
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.
"Today’s FDA approval of
Kynamro is great news for patients with HoFH who are in need of
additional treatment options for this rare, and often
under-diagnosed disease," Genzyme president and CEO, David Meeker,
said in a statement.
Isis, based in Carlsbad, Calif.,
has a deal with Genzyme, a unit of French drug maker Sanofi SA, to
market the drug if it is approved. The FDA approval triggers a $25
million milestone payment to Isis from Genzyme.
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
Shares of Isis shot up $1.03, or
7.70 percent, to $14.41 in after-hours trading on the news.
Posted: January 2013