FDA Prepares to Review Breakthrough Anti-Cholesterol Drugs

Federal health regulators prepare to review a new class of cholesterol-lowering drugs in a Wednesday meeting.

Among the drugs to be reviewed is Amgen, Inc.’s new drug Repatha, an injectable, cholesterol-reducing drug that patients can administer to themselves. The drug significantly lowered patients’ bad cholesterol by 60 percent, on average, and without any major side effects.

Amgen’s Repatha and other emerging biotech drugs could be part of the first major breakthrough in coronary heart-disease since statin pills were first introduced in the late 1980s. Statins, such as Lipitor from Pfizer Inc. and Crestor from AstraZeneca PLC, currently lead efforts to lower bad LDL cholesterol and reduce the risk of heart attacks and strokes. Doctors have been in search of another option, however, because millions of people with high cholesterol cannot tolerate statins.

If approved, the drug would provide patients and physicians with an important new treatment option for managing high cholesterol,”

Sean Harper, Amgen’s R&D head, said in a statement.

Repatha, if approved, could become the industry’s biggest-selling new drug, given the current size of the lipid-lowering market. Analysts at brokerage firm Goldman Sachs expects global annual sales to reach as much as $10 billion.

Despite its seemingly positive potential impact, Amgen, Inc. could face resistance from health plans and managers. Analysts at Sanford C. Bernstein & Co. predict that the price of the drug could be as much as $1,000 a month, which would create an unprecedented annual burden of close to $150 billion on the healthcare system.

Another concern the FDA has discussed with companies is whether the use of drugs could raise the risk for side effects such as memory impairment or delirium. Companies responded saying that they continue to study the matter, but thus far, testing does not suggest a heightened risk for patients.

Read more here- “FDA queues up review of new anti-cholesterol drugs” (Jonathon Rockoff, MarketWatch)

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Mackenzie is a Marketing Fellow and a rising junior at Villanova University. She is planning to co-major in Marketing and Finance and minor in Business Entrepreneurship. As a part of her studies, she has created and presented a comprehensive marketing plan to professionals from The Vanguard Group featuring Vanguard's exchange-traded funds.


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