Will the FDA Approval Expanded Label for Vascepa?

I know the PDUFA is in September but when are the insiders expecting a decision on expanded label for Amarin's Vascepa?

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Here is the Matinas CEO in an interview post Vascepa label expansion, saying everything that JT meant to say on CNBC but couldn't articulate properly.


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And there we have it....approval.


The U.S. Food and Drug Administration today approved the use of Vascepa (icosapent ethyl) as an adjunctive (secondary) therapy to reduce the risk of cardiovascular events among adults with elevated triglyceride levels (a type of fat in the blood) of 150 milligrams per deciliter or higher. Patients must also have either established cardiovascular disease or diabetes and two or more additional risk factors for cardiovascular disease. Patients are advised to continue physical activity and maintain a healthy diet.

“The FDA recognizes there is a need for additional medical treatments for cardiovascular disease,” said John Sharretts, M.D., acting deputy director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research. “Today’s approval will give patients with elevated triglycerides and other important risk factors, including heart disease, stroke and diabetes, an adjunctive treatment option that can help decrease their risk of cardiovascular events.”

What a horrible label! 150 and not 135 and only Secondary!

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Here is the footnote from the response to MRC.

And there we have it....approval.


The U.S. Food and Drug Administration today approved the use of Vascepa (icosapent ethyl) as an adjunctive (secondary) therapy to reduce the risk of cardiovascular events among adults with elevated triglyceride levels (a type of fat in the blood) of 150 milligrams per deciliter or higher. Patients must also have either established cardiovascular disease or diabetes and two or more additional risk factors for cardiovascular disease. Patients are advised to continue physical activity and maintain a healthy diet.

“The FDA recognizes there is a need for additional medical treatments for cardiovascular disease,” said John Sharretts, M.D., acting deputy director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research. “Today’s approval will give patients with elevated triglycerides and other important risk factors, including heart disease, stroke and diabetes, an adjunctive treatment option that can help decrease their risk of cardiovascular events.”

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AMRN stock was halted starting around noon and was still halted at the close. The rumor is that the FDA response to MRC's citizen petition very strongly hinted towards an approval of primary and secondary. Still ridiculous that the stock was still halted through the end of the day. Imagine holding options that expire today.

Here is the footnote from the response to MRC.

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There is no news yet but the FDA responded to MRC's citizen petition and put him in his place, but may have hinted to some great and imminent news.

AMRN stock was halted starting around noon and was still halted at the close. The rumor is that the FDA response to MRC's citizen petition very strongly hinted towards an approval of primary and secondary. Still ridiculous that the stock was still halted through the end of the day. Imagine holding options that expire today.

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There is no news yet but the FDA responded to MRC's citizen petition and put him in his place, but may have hinted to some great and imminent news.

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November 14, 2019 --

Next up, briefing docs.

The committee will discuss supplemental new drug application 202057/S-035, for VASCEPA (icosapent ethyl) capsules for oral administration, sponsored by Amarin Pharma Inc., for the following proposed indication: To reduce the risk of cardiovascular events, as an adjunct to statin therapy in adult patients with elevated triglycerides levels (135 mg/dL or greater) and other risk factors for cardiovascular disease, based on the results of a clinical study entitled “A Study of AMR101 to Evaluate Its Ability to Reduce Cardiovascular Events in High Risk Patients With Hypertriglyceridemia and on Statin.

The Primary Objective is to Evaluate the Effect of 4 g/Day AMR101 for Preventing the Occurrence of a First Major Cardiovascular Event. (REDUCE-IT)” (available at: https://clinicaltrials.gov/ct2/show/NCT01492361).


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It's going to be really hard for the FDA to prevent a label expansion at this point!!!!!

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AdCom Set --

The FDA's Endocrinologic and Metabolic Drugs Advisory Committee will meet on Thursday, November 14, to review and discuss Amarin's (NASDAQ:AMRN) supplemental marketing application seeking a cardiovascular (CV) benefit claim for Vascepa (icosapent ethyl).

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Doesn't matter now.

The FDA sent notice today that they plan on holding an advisory committee meeting (AdCom), tentatively scheduled for November 14, 2019, in connection with its review of the pending supplemental new drug application (sNDA) for expansion of Vascepa (icosapent ethyl) labeling based on the REDUCE-IT cardiovascular outcomes study.

Stock down 17% on the news.

November, December....WTH!?!?!?!

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Doesn't matter now.

The FDA sent notice today that they plan on holding an advisory committee meeting (AdCom), tentatively scheduled for November 14, 2019, in connection with its review of the pending supplemental new drug application (sNDA) for expansion of Vascepa (icosapent ethyl) labeling based on the REDUCE-IT cardiovascular outcomes study.

Stock down 17% on the news.

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