New Cholesterol and Alzheimer's Drugs
FROM THE DESK OF THE CMO
We have two items to discuss with our loyal patients:
1. New lipid drugs
2. New Alzheimer's drug
New Lipid Drugs-
1. Although not exactly breaking news, over the last year or so, forgotten during Covid, two different types of medications for lowering lipids were FDA approved. They are only now being marketed heavily.
First, Nexletol is NOT a statin, simply put, it reduces the amount of cholesterol made in your liver. Like statins, unfortunately it may increase your liver function tests. And give muscle aches. It is otherwise safe.
The catch? It is expensive, many health plans will not cover easily, and it is only approved for familial hyperlipidemias or known cases of Atherosclerotic vascular disease. In other words, not for low-risk patients to prevent heart attacks. In fact, it has not been shown to reduce heart attacks or strokes. It also may trigger gout attacks.
Second, Repatha (Evolocumab) Injection is a human monoclonal immunoglobulin used as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease. It is a shot that is self- administered once or twice a month. It does not replace statins; it requires that statins be tried and failed.
Like Nexletol, it is expensive, poorly covered, and not indicated for primary prevention. Unlike Nexletol, it does not mess with your liver function tests or cause muscle aches.
These new lipid drugs may help a small percentage of our patients who need an alternative to statins. Because neither are shown to reduce heart attacks or strokes, and are very expensive, we do not envision our doctors advising them widely.
If you have not had your lipids checked in the past 12 months, please pop in for a lipid panel. No office visit required.
2. New Alzheimer's Drug-
Last week, after initially rejecting Biogen's application, the FDA reversed course and approved Aduhelm (Aducanumab) salvaging literally billions of dollars in research and development.
It works by reducing a sticky brain substance called amyloid, which should benefit Alzheimer patients.
It was not without controversy.
One example is a panel of Alzheimer's experts advised rejecting the drug, asking for more and better studies.
Once their advice was rejected, three of the panel resigned.
“This might be the worst approval decision that the F.D.A. has made that I can remember,” said Dr. Aaron Kesselheim, a professor of medicine at Harvard Medical School and Brigham and Women’s Hospital, who submitted his resignation Thursday after six years on the committee.
He said the agency’s approval of the drug, a monthly intravenous infusion that Biogen has priced at $56,000 per year, was wrong “because of so many different factors, starting from the fact that there’s no good evidence that the drug works.”
The approval comes as a possible grand slam homer for Biogen, who was struggling lately for lack of new drugs.
The last new Alzheimer's drug that was FDA approved was way back in 2003.
The trouble Biogen will have been that it is indicated only for mild cognitive impairment--in other words, early cases. Or have documented amyloid in their brain. Worse, it requires a monthly IV infusion at an infusion center.
AND monthly MRI tests to look for brain bleeds, a known side effect.
Being limited to early Alzheimer's cases only, poor health plan coverage due to a very high price point, and IV infusion requirements, make this drug unattractive. But in the right patient, it may afford hope for symptom improvement.
If you or a loved one is experiencing memory or depression symptoms post Covid, please schedule a check for an in-office Alzheimer's screening.