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    Home > Medical News > Latest Medical News > FDA approves AMRN pure EPA fish oil preparation Vascepa label extension application

    FDA approves AMRN pure EPA fish oil preparation Vascepa label extension application

    • Last Update: 2020-05-31
    • Source: Internet
    • Author: User
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    On the 14th, the FDA approved an extension application for the AMRN pure EPA fish oil preparation Vascepa label, and patients with no cardiovascular history, no history of cardiovascular disease but diabetes plus two other cardiovascular risk factors can use Vascepa as a preventive treatment for cardiovascular disease on the basis of the maximum tolerable dose of statinsAlthough primary prevention is limited to high-risk groups, the minimum tG is set at 150 mg/dL, a label that is generous although not home." It is estimated that the u.Spopulation alone could reach tens of millions of people, and Vascepa's peak sales could reach $4 billionthe analysis of the drug source
    Vascepa's story we've told a few times, and interested readers can flip through the old text, which is an inspirational story of a big betThe approval, which was two weeks ahead of the PDUFA date, was not a surprise, as an external panel of experts voted 16-0 last month to support the label extensionThe FDA's decision today is expected because it now approves new drugs several months in advance, and some controversial products such as yesterday's DMD drug Vyondys 53 are also on the marketVascepa was introduced in 2012 for TG control for patients with severe lyglycerides (?500mg/dL) and the following year it was rejected by the expert group to extend the label to 250-500mg/mLIt can now be used for secondary prevention and primary prevention in all patients above 150 mg/mL, both in terms of the applicable population and the potential benefits of a giant leapthere are several fish oil products on the market, but Vascepa is the only product with a cardiovascular prevention label, which is sure to make the product a focus of the generic sonEPA is an old compound, so the substance patent has long since existedARMN now has more than a hundred formulations and patents for use, but these patents are generally less tightly protected than substance patentsAccording to experts estimate that ARMN's patent itself is still relatively strong, but indirect infringement is not good to resistCompetitors can sell other EPA preparations in the name of lower IngG but doctors can use these cheap products for CV preventionARMN has only reached an agreement with Teva to guarantee that it will not compete ugtimeal ugtime, but both Hikma and Dr Reddy's are ready to challenge the patents in the near futurecardiovascular disease is the world's number one killer but as drug development becomes increasingly difficult for many companies to no longer compete in the field, This week Sanofi just announced that he is leaving the battleground of its ownThe decline of competitors has made a few successful drugs even more surprising, and ARMN's market capitalisation is now close to $10 billionThis market value is also the size of the acquisition preferred by the big drugmakers, because it can significantly improve sales without having a significant impact on the company's structureIf the acquisition obviously AMRN investors will get higher returns, but I think AMRN this kind of gambling strategy occasionally can also, not large-scale promotionNew drugs have found that they rely on luck, but too late, and as accurately as many complex things, to determine where that line is drawn to test the wisdom of decision makersoriginal title: OriginalFDA approves expansion of Vascepa label
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