Health Care

New Cholesterol Drug Effective but Expensive

New Cholesterol Drug Effective but Expensive”

Sanofi SA and Regeneron Pharmaceuticals Inc announced that the ODYSSEY OUTCOMES trial met its primary endpoint, showing Praluent (alirocumab) Injection significantly reduced the risk of major adverse cardiovascular events (MACE) in patients who had suffered a recent acute coronary syndrome (ACS) event such as a heart attack.

Regeneron/Sanofi heart drug succeeds in major trial; Will insurers pay?

In a pre-specified analysis, the patients with baseline LDL cholesterol (LDL-C) levels at or above 100 mg/dL experienced a more pronounced effect from alirocumab, reducing their risk of MACE by 24% (HR=0.76, CI: 0.65-0.87), and in a post-hoc analysis of the same group, the drug was associated with a lower risk of death from any cause by 29% (HR=0.71, CI: 0.56-0.90). That price would be tied to an independent review of Praluent's value based on the new risk reduction data from the multi-year study called Odyssey Outcomes. Management sees population of 300K - 400K high-risk patients in US, only 38K being treated at present.

The study tested the injected biotech drug versus placebo in almost 19,000 patients who had a recent heart attack or severe chest pain episode and were already on maximum doses of cholesterol-lowering statins, such as Pfizer's Lipitor. Despite their striking ability to lower gobs of LDL-C or "bad" cholesterol, their sales have been meager compared to Wall Street analysts' initial bullish multi-billion dollar projections; alirocumab tallied $194 million a year ago worldwide, evolocumab $319 million.

The results give a clear advantage to Sanofi and Regeneron in the duel with Repatha, which like Praluent, is a PCSK9 inhibitor drug. The high-risk group is the estimated 1.3 million people in the US and Europe who have had heart attacks or strokes and still can't get their LDL-C levels below 100 mg/dL of blood despite treatment with statins.

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With an LDL target range of 25-50, rather than taking it as low as possible, three-quarters of patients ended up on a lower dose of Praluent and some were taken off the drug if their LDL remained at 15 or lower. If LDL cholesterol levels dropped consistently below 15 mg/dL, the patient was switched to placebo, again in a blinded fashion. Patients were tracked for at least two years, including 44 percent who were tracked for three years or more. Overall, the primary endpoint occurred in 9.5 percent of those receiving alirocumab and 11.1 percent of those receiving placebo, while 3.5 percent of those receiving alirocumab and 4.1 percent of those receiving placebo died.

A newer cholesterol drug, used with older statin medicines, modestly lowered heart risks and deaths in a big study of heart attack survivors that might persuade insurers to cover the pricey treatment more often. There was no difference in neurocognitive events or new-onset diabetes. "In this trial, such patients who received Praluent on top of maximally-tolerated statins had important reductions in their risk", commented George Yancopoulos, president and chief scientific officer at Regeneron.

Insurers have balked at paying for Praluent and a rival Amgen drug, which dramatically lower "bad" LDL cholesterol but carry list prices of more than $14,000 a year before discounts, over fear of the cost of use over many years by millions of patients.

"Now that we have two trials that consistently show benefits from PCSK9 inhibitors, and given the mortality benefit that we are reporting here for the first time, I think these results may change the equation for these drugs", Steg said.

Researchers will continue to track patient outcomes for up to 10 years to determine whether the benefits continue after stopping the drug.

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