First PCSK9 Outcome Trial Results Pushed Back To 2017

Uptake of the new drugs likely to lag without strong outcomes data. Uptake of the new drugs likely to lag without strong outcomes data.Uptake of the new drugs likely to lag without strong outcomes data.   –Uptake of the new drugs likely to lag without strong outcomes data. There’s probably nothing more eagerly awaited in cardiovascular…

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Court Decision In Patent Battle Threatens PCSK9 Drug

—-One analyst thinks the decision might take Praluent off the market. A jury’s decision last week in a patent case might possibly lead to the removal of one of the new PCSK9 inhibitor cholesterol lowering drugs from the US market, according to a Wall Street analyst who has been closely following the case. Amgen, which…

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Amgen Denies Rumors About PCSK9 Inhibitors (Updated)

(Updated) Amgen says there is no truth to the rumor that the FDA is investigating post-marketing reports of serious brain infections in patients taking PCSK9 inhibitors. The Amgen statement was in response to this anonymous post on CafePharma: “The FDA informed Amgen and Regeneron today that there have been a number of post marketing reports…

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Amgen’s Repatha Beats Out Competitor For Spot On CVS/Caremark Formulary

CVS Health announced today that Amgen’s Repatha will be the only PCSK9 inhibitor on the CVS/Caremark formulary. This gives Amgen its first big win among the pharmacy benefits managers against Sanofi’s Praluent in the battle over the market for the powerful but expensive new cholesterol-lowering drugs. Previously Express Scripts had announced that both drugs would be placed…

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Amgen Takes The Pledge To Respect Patient Privacy

In response to criticism Amgen appears to have greatly tightened its corporate privacy policy regarding patient information. The company has published a “privacy pledge” to US patients” and says that it will  soon modify the authorization agreements that required patients participating in the company’s drug copay programs to surrender rights to their personal and health information. The move…

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Amgen Requires Patients in Repatha Copay Program To Surrender Their Privacy

(This story was updated on October 23 with a statement from Amgen. It was again updated on October 27 with new information about Amgen’s patient privacy policy for a second drug, Enbrel.) (For an important followup to this story please see:  Amgen Takes The Pledge To Respect Patient Privacy) The tumult over the new cholesterol…

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Desperately Seeking Patients: New Cholesterol Drug Makers Fuel Research To Find Customers

Everyone expects that the makers of the new PCSK9 inhibitor cholesterol lowering drugs are going to make billions and billions of dollars from these innovative new drugs. But before that can happen the companies that make the drugs will need to find the patients who will take the drug. To help find these patients a central strategy…

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‘Cardiology On A Collision Course With Specialty Pharmaceutical Pricing Models’

The recent approval of two new expensive cholesterol drugs “sets the practice of cardiology on a collision course with specialty pharmaceutical pricing models that were previously reserved for drugs that benefited relatively limited patient populations,” according to the authors of a perspective published in the New England Journal of Medicine. Until now cardiologists and other doctors treating the…

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New Cholesterol Drugs Gain Entry To Large Formulary

The two big and expensive new cholesterol drugs that everyone is talking about have both been added to the national preferred formulary of Express Scripts, the nation’s largest pharmacy benefit manager. The drugs– alirocumab (Praluent, from Regeneron and Sanofi) and evolocumab (Repatha, from Amgen)– are potent but expensive drugs that inhibit PCSK9 and dramatically lower LDL cholesterol. Both drugs…

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FDA Approves Repatha, Amgen’s PCSK9 Inhibitor

Late on Thursday Amgen announced that the FDA had approved its highly anticipated and much debated PCSK9 inhibitor, Repatha (evolocumab). The drug will be the second PCSK9 inhibitor on the market, following the approval last month of Sanofi’s and Regeneron’s  Praluent (alirocumab). In a press release the FDA said Repatha “is approved for use in addition to diet…

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FDA Approval Of Second PCSK9 Inhibitor Expected Soon

The FDA has until Thursday, August 27 to make its decision about Repatha (evolocumab), Amgen’s much anticipated cholesterol lowering PCSK9 inhibitor. The drug is widely expected to gain approval. Last month the FDA approved Praluent (alirocumab), Sanofi’s and Regeneron’s similar drug. Beyond approval the major questions that should be answered this week concern the drug’s label…

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More Preliminary Signs That PCSK9 Inhibitors May Improve Outcomes

More information about the highly anticipated new cholesterol lowering drugs from Amgen and Sanofi/Regeneron emerged today. A new new analysis of available data from early trials with PCSK9 inhibitors adds to the growing evidence showing that the drugs– Amgen’s evolocumab and Sanofi’s alirocumab– dramatically lower LDL cholesterol and offers additional preliminary evidence showing that they are safe and may confer a…

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FDA Approves Amgen Heart Failure Drug

The FDA on Wednesday approved ivabradine (Corlanor), Amgen’s new heart failure drug. The drug has been available for several years in Europe, where it is sold by Servier under the brand names of Corlentor and Procoralan. Ivabradine was approved for the reduction of hospitalization from worsening heart failure. … Click here to read the full post on Forbes.    …

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Should You Be Worried About The Neurocognitive Side Effects Of The New Cholesterol Drugs?

The big news yesterday was important additional information about the new cholesterol lowering PCSK9 inhibitors from Amgen and Sanofi/Regeneron. As I reported then, the studies were broadly consistent, showing the powerful cholesterol-lowering effects of the drugs and providing an early suggestion that the drugs may lead to significant reductions in heart attacks, stroke, and other cardiovascular events. But one finding, though not…

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No, The New Cholesterol Drugs From Sanofi And Amgen Aren’t Going To Cost $150 Billion A Year

In an article on the Health Affairs blog 4 CVS executives speculate that the new cholesterol lowering PCSK9 inhibitors from Amgen and Sanofi might achieve yearly sales of $150 billion or even higher. I think these numbers are a bit silly. But first let’s take a look at their extremely bullish case…. … Click here to read the full post on Forbes.  …

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Sanofi And Regeneron Leapfrog Amgen In New Cholesterol Drug Race

Early on Monday Sanofi and Regeneron leapfrogged their rival Amgen to gain leadership in the race to bring a new class of cholesterol drugs to market. The new development could potentially give Sanofi and Regeneron a month on the market by itself before facing competition from Amgen. Sanofi and Regeneron announced early on Monday that the FDA had accepted for priority review the Biologics…

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European Review Confirms Increased Risk with Ivabradine

Following a review provoked by troubling findings that emerged from a large clinical trial, the European Medicines Agency (EMA) is making several recommendations intended to lower the risk of heart problems linked to the heart-rate-lowering drug ivabradine. The drug is marketed by Servier in Europe under the brand names of Corlentor and Procoralan and is indicated for…

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At the American Heart Association Meeting You Really Can’t Escape The New Cholesterol Drugs

There’s no escaping them. At the American Heart Association in Chicago going on right now Amgen and Sanofi/Regeneron, which are developing competing cholesterol lowering drugs known as PCSK9 inhibitors, have mounted a full scale attack to capture the eyeballs and the brains of cardiologists and any other innocent bystanders who happen to be at the…

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SIGNIFY Trial Provokes Sound And Fury Over Controversial Servier and Amgen Drug

The controversial drug ivabradine just got a little more controversial. The drug, which is marketed by Servier under the brand names of Corlentor and Procoralan, is available in Europe and elsewhere and is used for the treatment of heart failure and stable angina. The drug is not available in the US, but it is under development by Amgen for a heart…

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Silencio! Claiming Pressure From European Regulators, Trial Leaders Cancel Press Conference

Investigators of the much-anticipated and controversial SIGNIFY trial have told the European Society of Cardiology leadership that they will not participate in a previously scheduled press conference on Sunday at the society’s main meeting in Barcelona. But they say they will present the main results of their trial at a Hot Line session later in the afternoon….

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Sharp Scrutiny From European Medicines Agency Of Amgen And Servier Heart Drug

There may be trouble on the horizon for ivabradine, a heart drug marketed by Servier under the brand names of Corlentor and Procoralan. The drug is widely available in Europe and elsewhere, though it is not available in the US, where it is under development by Amgen. Although it hasn’t been widely noticed– I can find no other…

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FDA Grants Fast Track Status To Amgen Heart Failure Drug

Amgen announced yesterday that its new chronic heart failure drug ivabradine had been granted fast track status by the FDA. The company said the fast track designation, which is for drugs that treat serious conditions and fill an umet medical need, will aid the development and speed the review of the drug. … Click here to read the…

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New Guideline Recommends Conservative Treatment for Heart Patients with Anemia

The American College of Physicians (ACP) is recommending more conservative use of transfusions and erythropoiesis-stimulating agents (ESAs) in anemia patients with heart disease. But the authors of the new clinical practice guidelines, published in the Annals of Internal Medicine, acknowledge that the evidence base is too flimsy to support firm conclusions. “Overall,” wrote the authors, “despite the epidemiologic and…

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The Fate Of New Cholesterol Drugs Depends On IMPROVE-IT

Prospects for the highly anticipated new class of cholesterol-lowering drugs, the PCSK9 inhibitors, took a wild roller coaster ride this week. The publication of new lipid guidelines by the American Heart Association and the American College of Cardiology led many observers to think that the promising new drugs under development by Regeneron (in partnership with Sanofi),…

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Amgen Trial Fails To Show Benefit Of Anemia Drug In Heart Failure Patients

  The bad news continues for Aranesp (darbepoetin alfa), Amgen’s long-acting erythropoietin-stimulating agent. The drug is intended to stimulate red cell blood production in patients with anemia. Amgen today announced the top line results of a large phase 3 heart failure trial of the drug and said  the trial had failed to meet its primary endpoint.   The RED-HF…

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