Drug Approval Signals New Options for Stroke, Heart Attack Survivors in Europe

This week, the European Commission approved a groundbreaking new drug, evolocumab, to prevent heart attack and stroke for patients who have already survived a cardiac event.  The approval marks the entry of an important new tool for secondary prevention.

Evolocumab is a PCSK9 inhibitor, which reduces cardiovascular risk by lowering a patient’s level of LDL, or “bad,” cholesterol.  The drugs are designed for patients whose statin therapy alone does not sufficiently lower their high cholesterol. In clinical trials, the drug reduced patients’ risk of heart attack by 27 percent and stroke by 21 percent.  Evolocumab was already approved in Europe to treat genetic high cholesterol, known as familial hypercholesterolemia.

More treatment options are a welcome advance for patients and clinicians in Europe.  Diseases of the circulatory system, such as heart attack and stroke, cause approximately half of deaths in the European Region, according to the World Health Organization. Cases of cardiovascular disease have risen over the past 25 years.

Now the region must turn to the issue of access.

Evolocumab’s manufacturer voiced its willing to work “in partnership” with the region’s health care payers to expand patients’ access to the therapy.  Meanwhile, advocates will need to wage an equally collaborative effort to educate payers with up-to-date information on treatment options – and to cultivate policies that ensure patients can access a PCSK9 inhibitor when they and their physicians have decided it is the best treatment option.