The FDA advisory panel considers this week an experimental drug to lower cholesterol whose approval would lead to blockbuster medicines with a potential for billions of dollars in sales.
Avolocumab from Amgen Inc. and alirocumab from Sanofi SA and Regeneron Pharmaceuticals Inc., is being evaluated by the panel. The new agents to lower LDL would be the first major additions to the coronary disease medicine coffer since the first prescription of the statin pills in the late 1980s.
“This is the next big quantum leap in being able to control cholesterol and potentially reduce the risk of heart attacks and strokes,” the cardiovascular and metabolic program head at Regeneron, Bill Sasiela said.
Statins, such as Pfizer’s Lipitor and AstraZeneca’s Crestor, will remain the backbone to lower “bad” LDL cholesterol for heart attack and stroke risk reduction. Yet, specialists have looked for other options because a lot of patients with high cholesterol are unable to tolerate statins or control their cholesterol levels by using the drugs.
A protein called PCSK9, that interferes with the liver’s ability to clear bad cholesterol, is blocked by this new biotech drugs. Both are in injectable form that allows for patients to administer to themselves at home. Studies indicate a dramatic decrease of bad cholesterol levels in patients, and studies show the drugs to be safe.
One concern, though, is that the use of the drugs could raise side effect risks such as delirium or memory impairment. The companies say, although the matter is being studied by them, so far, it doesn’t heighten any significant risk.
It is also unclear if the cholesterol reductions of patients taking the new agents reduce risk of heart attacks and strokes, but the FDA accepts that substantial lowering of bad cholesterol render cutting down cardiovascular risks. Company-initiated “outcomes” studies that probe the issue are under way and are expected to finish in 2017 or maybe earlier.
The PCSK9 has the potential to be among the industry’s biggest-selling new classes, given the market’s size. Annual worldwide sales may reach up to $10 billion, the brokerage firm Goldman Sachs Group Inc. estimates.