Repatha, $14K Drug, Cuts Heart Risks But Expense May Prevent Its Use

Pablo Tucker
March 20, 2017

By 2021, Repatha sales are expected to reach $3.9 billion, according to the consensus estimate compiled by FactSet.

Even as uptake remains slow for Amgen's Repatha (evolocumab) and Sanofi's Praluent (alirocumab), The Medicines Co. hopes to carve out a niche for itself in the PCSK9 market. The company believes the study results meet that goal. "It is a very good story in that regard", said Amgen's Harper. Now, a large clinical trial has demonstrated that this approach can lower the risk of heart disease.

Prof Sever added: "They would have another 20 percent reduction in risk and that is a big effect". Insurance companies have been trying to escape costly Repatha and have asked the company to provide better proof of reduction in heart disease risk.

Galena Biopharma Inc. ( GALE ) on Friday reported positive final results from its investigator-sponsored phase 1/2a clinical trial of GALE-301 for the prevention of cancer recurrence in ovarian and endometrial cancer patients in the adjuvant setting.

According to the Centers for Disease Control and Prevention, around 610,000 people die each year in the United States as a outcome of heart disease. Half of these patients were given optimal quantity of statins along with Repatha, and the other half were given a placebo. Can the findings turn this PCSK9 drug into the blockbuster that many had been predicting since Amgen won FDA marketing approval for it in August 2015?

Meanwhile, Esperion Therapeutics is working on a cholesterol-lowering drug of its own called bempedoic acid.

The main goal, or primary endpoint, of the FOURIER study was to determine if longer-term use of Repatha could reduce the risk of cardiovascular death, heart attack, stroke, hospitalization for unstable angina or coronary revascularization. Patients would receive refunds for the cholesterol drug's medical costs, but with the caveat that they need to have had a heart attack or stroke while on Repatha.

The FOURIER (Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk) trial--a multinational, phase 3, randomized, double-blind, placebo-controlled study--was created to evaluate whether treatment with evolocumab in combination with statin therapy compared with placebo plus statin therapy reduces cardiovascular events.

Dr Marc Sabatine, from Brigham and Women's Hospital in MA and lead researcher on the study, will present the findings today (17th March) at the American College of Cardiology's (ACC) 66th Annual Scientific Session in Washington.

In the study, published today in the New England Journal of Medicine, researchers looked at the protective effect of evolocumab on patients in 49 countries, with a history of atherosclerotic vascular disease, who were already taking statins to reduce their cholesterol. The British Heart Foundation said the findings were a significant advance in fighting the biggest killer in the world. Treatment with evolocumab significantly reduced the risk of primary endpoint compared with placebo (1344 patients vs 1563 patients, respectively), and the key secondary endpoint (816 vs 1013, respectively). The money-back guarantee will be available to patients that suffer a heart attack or stroke while taking Repatha.

As for safety, "patients who achieved the lowest levels of LDL, the lowest quartile, saw levels of 19 or less", Levy said, "and the safety profile in those patients was also pristine".

This reduction in risk improved over time, increasing from 16 per cent in the first year to 25 per cent after the first year, the researchers said.

At baseline, the average LDL was 92 mg/d, but after 48 weeks the median was just 30 mg/d (P 0.001).

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