FDA approves first fish-oil drug for cutting cardiac risks
Amarin funded a five-year study of nearly 8,200 patients at high cardiac risk who were already taking medicines to lower bad cholesterol or control diabetes. The half who took Vascepa capsules along with those medicines had a 25 percent lower chance of heart complications and a 20 percent lower risk of death, compared with those adding dummy capsules of mineral oil to their medicines.
Slightly more patients getting Amarin's drug had an irregular heartbeat than those taking the dummy capsules, but other side effects were minor.Heart disease affects an estimated 121 million American adults, causes aboutand costs more than $500 billion annually for treatment, according to the American Heart Association.
Vascepa sales brought Amarin just $287 million over 2019's first nine months, but analysts forecast the much-broader approval could boost annual sales to $3 billion or more.: A previous version of this article misstated when the FDA approved a fish-oil drug for cardiac risks. The drug, Vascepa, was previously approved; the FDA has now expanded its use.
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