Rat Study Links Neural Tube Defects To Lower PCSK9 Levels

(Updated) PCSK9 may play an important role in neural tube development (NTD), a new study in rats suggests. The study, published in Scientific Reports, found that PCSK9 levels were significantly reduced in rat embryos with NTDs. The main focus of the paper was to identify biomarkers that could be used for the prenatal detection of NTDs, since there are now…

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First Outcomes Trial Results For PCSK9 Drugs Will Come In 2016

In less than a year we may know a whole lot more about the PCSK9 inhibitors than we do now. Since the approval earlier this year of Repatha (evolocumab, Amgen) and Praluent (alirocumab, Regeneron and Sanofi) critics and benefit managers have recommended strict limitations on use of the drugs because of the absence of evidence showing clinical benefit….

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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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New Definition Of Familial Hypercholesterolemia Could Expand Patient Population For Expensive Cholesterol Drugs

More people may be diagnosed with familial hypercholesterolemia (FH) using criteria contained in a new scientific statement published by the American Heart Association. The expanded definition could also mean more patients will be eligible to receive expensive cholesterol-lowering drugs, including the new PCSK9 inhibitor drugs, (Repatha from Amgen and Praluent from Sanofi/Regeneron). But the biggest impact might be to increase the…

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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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More Questions About Nonprofit Groups And Industry Support

In response to my article about commercial funding of nonprofit organizations from the manufacturers of the PCSK9 inhibitors, Joshua Knowles wrote an eloquent and heartfelt defense of the FH Foundation, which receives some funding from industry. But I think he fails to address the fundamental underlying issues I wrote about in my piece. Knowles writes that “FH is a…

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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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New Cholesterol Drugs Not Breaking The Bank– Yet

Sales of the new cholesterol-lowering PCSK9 inhibitors have been lower than some had anticipated, the nation’s largest pharmacy benefit manager, Express Scripts, disclosed in a Reuters news story. The majority of prescriptions have been rejected by Express Scripts “because patients did not meet required medical criteria,” Reuters reported. “We’re seeing a lot of patients who either don’t qualify or…

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Report Concludes That PCSK9 Inhibitors Are Effective But Very Expensive

The new PCSK9 inhibitors– with an annual cost of over $14,000 a year– are far too expensive to be broadly used in eligible populations without restrictions, according to a draft report from the Institute for Clinical and Economic Review (ICER). The price of the new drugs would need to fall to nearly $2,000 in order for the drugs to…

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Novel Drug Could Cut LDL With Just 2 Or 4 Shots A Year

A novel drug still in phase 1 studies could dramatically lower cholesterol with only a few injections each year. Because the drug could be given during regular visits to the doctor it might help solve the thorny problem of drug compliance and adherence. Like the recently approved monoclonal antibodies alirocumab and evolocumab, the drug targets PCSK9 to lower LDL,…

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Cholesterol Wars: The Reimbursement Battle Begins

(Updated) The next stage of the cholesterol wars has officially started. With the recent approval of Repatha (evolocumab, Amgen) and Praluent (alirocumab, Sanofi and Regeneron) the big immediate question everybody wanted answered was how the battle to pay for these expensive drugs (the wholesale acquisition cost is more than $14,000/year for both drugs) would shape…

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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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Can You Test A Drug And Also Say Negative Things About It?

In my last post I raised the possibility that Steve Nissen, a highly influential cardiologist who has been an outspoken critic of industry influence in medicine, might have his own conflict of interest (COI) problem. In response, another cardiologist, James Stein, said that my post was unfair in its treatment of Nissen and failed to…

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Steven Nissen, Conflicts Of Interest, And The New Cholesterol Drugs

(Updated) Does Steve Nissen, an outspoken critic of inappropriate industry influence in medicine, have his own conflict of interest problem? This week Nissen, the chief of cardiology at the Cleveland Clinic, was widely quoted in news reports about the FDA advisory panels evaluating two new highly promising cholesterol drugs from Amgen and Sanofi/Regeneron. Nissen was broadly supportive of the drugs….

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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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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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New Cholesterol Drugs: Highly Effective But Important Questions Remain

New information emerged today about two new cholesterol-lowering drugs that have been attracting a lot of attention. Data about the PCSK9 inhibitors– evolocumab, under development by Amgen, and alirocumab, under development by Sanofi and Regeneron– were published in the New England Journal of Medicine. The effects of the two drugs appeared to be broadly consistent. Both lowered LDL cholesterol powerfully,…

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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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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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