) is seeking approval for a label expansion of its drug Vascepa.
Amarin is seeking to get Vascepa approved as an adjunct to diet
and exercise and in combination with a statin for treating adults
with high triglyceride levels (≥200 mg/dL and <500 mg/dL) with
mixed dyslipidemia and coronary heart disease (CHD) or a CHD risk
equivalent. Amarin refers to this as the ANCHOR indication.
We remind investors that the U.S. Food and Drug Administration
(FDA) accepted Amarin's supplemental New Drug Application (sNDA)
for the ANCHOR indication in Apr 2013.
Amarin had requested the FDA to reinstate the ANCHOR Special
Protocol Assessment (SPA) agreement which is currently under
consideration with the regulatory body. Consequently, the FDA did
not take an action (PDUFA date - Dec 20, 2013) on Amarin's sNDA
for the ANCHOR indication of Vascepa.
The FDA will now view Amarin's appeal of the ANCHOR SPA
agreement rescission and the ANCHOR sNDA separately. Amarin's
request to reinstate the ANCHOR SPA agreement will be reviewed by
FDA before Jan 15, 2014.
We note that Vascepa, the only marketed product of the
company, is already approved in the U.S. as an adjunct to diet
for reducing triglyceride levels in adults suffering from severe
hypertriglyceridemia (triglyceride ≥ 500mg/dL). Amarin refers to
this as the MARINE indication. Amarin started marketing the drug
in the U.S. in Jan 2013 and. reported $8.4 million in sales of
Vascepa in the third quarter of 2013.
Amarin is leaving no stone unturned to successfully
commercialize Vascepa (MARINE indication) and expand the drug's
label into the ANCHOR indication.
Amarin carries a Zacks Rank #3 (Hold). Investors may
consider companies like
Enanta Pharmaceuticals, Inc.
, Jazz Pharmaceuticals
Questcor Pharmaceuticals Inc.
), all of which carry a Zacks Rank #1 (Strong Buy).
AMARIN CORP PLC (AMRN): Free Stock Analysis
ENANTA PHARMA (ENTA): Free Stock Analysis
JAZZ PHARMACEUT (JAZZ): Free Stock Analysis
QUESTCOR PHARMA (QCOR): Free Stock Analysis
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