New drug breakthrough dramatically cuts cholesterol

On the up side, 2 years of taking Repatha along with conventional statins reduced LDL, the bad cholesterol, from 92 to 30. JP Morgan also had the opportunity to speak with several doctors at the conference who further confirmed its view that, while Repatha is clearly a safe and effective drug, penetration may (at least in the near term) remain confined to more advanced patients, potentially making it hard to meet prevailing commercial expectations (details below). Repatha and Praluent cost more than $14,000 a year before discounts and rebates. In an editorial in The New England Journal of Medicine, Dr. Robin Dullaart, a researcher at the University of Groningen in the Netherlands, called it a landmark study. They were also less likely to suffer from a heart attack or stroke than those who took the placebo.

Not necessarily, say analysts, who reckon TMC and Alnylam can learn from experiences with the established drugs for their phase 3 program, which is due to start mid-year, and set themselves up for success.

Prof Sever added: "They would have another 20 percent reduction in risk and that is a big effect". The drug's mechanism of action was discovered by studying people with mutations to the gene for PCSK9 that allowed them to maintain exceptionally low cholesterol levels.

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One such drug is Repatha, this cholesterol reducing drug was cleared by the United States Food and Drug Association in 2015.

But data released on Friday showing its ability to prevent heart attacks and strokes proved to be underwhelming. More cautious doctors insisted they needed proof that it prevents heart attacks and strokes.

"Investors have grown more cautious on the PCSK9 space following the less-than-stellar Fourier data from Amgen", said the analysts in a research note. A study testing whether Praluent also lowers heart risks will wrap up later this year. It goes without saying that this added conviction from Amgen needs to translate into looser payer restrictions to make the high consensus commercial expectations for Repatha attainable (consensus for 2021 stands at just below $3B). Insurers and other payers look first at how well the drug works - not its cost - when they decide whether to cover the latest treatments, according to the nation's largest pharmacy benefits manager, Express Scripts.

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Now that the data on evolocumab are in, some health-care payers such as insurance companies and government programmes might be more willing to shoulder the treatment's steep cost. That committee - 15 doctors and a pharmacist - reviews the information that federal regulators used to approve a drug and then decides whether it should be covered.

The company said it plans to begin enrolling patients in a pivotal Phase III study for the drug, inclisiran, later this year. That can limit patient access. Many doctors wondered if such low levels would be unsafe, causing memory problems or dementia due to a lack of cholesterol, said Dr. Steven Nissen, chair of cardiovascular medicine at the Cleveland Clinic, who was not involved in the new research but has led clinical trials of PCSK9 inhibitors in the past. After diving deeper into the data, we think it will be sufficient to change treatment guidelines, and our assumptions for net USA prices-going from roughly $10,000 today to $8,000 annually over the next couple of years as payers loosen restrictions-still hold. Some lists are divided into tiers, with drugs on the bottom generally being generic or least expensive.

Anti-PCSK9 antibodies are the jewel in the crown of modern genomic medicine, illustrating what many hope will be a paradigm for future drug discovery. Injection site reactions were "rare" in both arms of the study, but slightly higher with Repatha patients, Levy said.

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