Published: Tue, March 21, 2017
Medical | By Garry George

New cholesterol drug proving successful

New cholesterol drug proving successful

However, Repatha is priced prohibitively expensive - a one-year supply runs $14,523 - and many insurance companies will not cover the drug without evidence it protects against heart attack and stroke in high risk patients. All of them were already receiving statin therapy.

Repatha, injected either once or twice a month, lowered LDL by about 60 per cent to a median of 30, with a quarter of patients getting below 20, researchers reported. They followed-up these people for two years, from 2013 to 2015.

The recommended LDL level by the doctors is below 100 milligrams per decilitre.

Although about 5% of patients in the clinical trial had a heart attack or stroke, rates of those problems could be two to three times higher in the real world, where patients are often older and sicker than those in clinical trials, Ofman said.

Repatha also showed a clean bill of health from a safety standpoint.

FOURIER is the first outcomes trial to read out for the PCSK9 class. Sanofi and Regeneron are conducting their own study, dubbed ODYSSEY, to test Praluent's cardiovascular benefit. Repatha was approved for people with an inherited condition that causes high LDL levels or who have underlying heart disease but haven't been able to adequately lower their LDL with statins alone. But any new cholesterol drug faces stiff competition from cheaper statins, which have been used to control LDL levels for decades.

But they were approved only for those with a genetic condition that means they have dangerously high cholesterol, and people with heart disease who can not cope with the side effects of statins. The result? Sales of Repatha came in at $141 million past year and Praluent made around $112 million, well shy of initial expectations. JP Morgan's view is that, given the data and the current payer environment, physicians will choose to reserve treatment for patients with multiple comorbidities and relatively higher LDLs than the cutoff for FOURIER ( 70mg/dL). "Creating new treatments which use this approach could prove life-saving for patients with high cholesterol and those who can't tolerate statins". More cautious doctors insisted they needed proof that it prevents heart attacks and strokes.

So far, PCSK9 drugs, which are monoclonal antibodies that inhibit proprotein convertase subtilisin-kexin type 9, haven't made the splash in the market that pharma watchers had expected and their makers had hoped. Statins can cut LDL levels by up to half and reduce heart attack risk by 25 percent, Nissen said.

The study found that for every 74 people who took the drug for two years, one heart attack or stroke would be prevented.

Repatha, administered by patients via an injection pen, blocks a protein that interferes with the liver's ability to remove cholesterol from the blood. It is called evolocumab and it functions by changing the way the liver works to also cut bad cholesterol.

"It sounds like the patient gets harmed and the payer has its financial risk reduced", said cardiologist Cam Patterson, chief operating officer at NewYork-Presbyterian Hospital/Weill Cornell Medical Center, who wasn't involved in the study.

"We now show for the first time in a dedicated outcomes study that decreasing LDL cholesterol with PCSK9 inhibition results in clinically meaningful cardiovascular benefit", said Marc S. Sabatine, M.D., M.P.H., chairman of the TIMI Study Group, the Lewis Dexter, MD, Distinguished Chair in Cardiovascular Medicine at Brigham and Women's Hospital, and Professor of Medicine, Harvard Medical School, Boston.

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