Tag Archives: FDA

January 7, 2023 · 3:18 pm

New year, new drug to treat Alzheimer’s approved by FDA

This week, the U.S. Food and Drug Administration approved a new drug to treat those in the early stages of Alzheimer’s disease. The approval of lecanemab was welcomed by the Alzheimer’s Association, who urged the Centers for Medicare & Medicaid Services to cover the cost for its members. Some members of the medical community have a more guarded view of this latest Alzheimer’s treatment, encouraging families to talk to their providers to understand the benefits and risks.

Here are some facts to know about lecanemab:

  • The drug, made by Eisai in collaboration with Biogen, is for those diagnosed with mild cognitive impairment or mild dementia stage of disease and confirmed presence of amyloid beta pathology, according to the FDA.
  • In a study cited by the FDA, those who took the drug experienced a statistically significant reduction in brain amyloid plaque versus those in the placebo group. While the connection between the presence of amyloid plaque in the brain and Alzheimer’s is still up for scientific debate, the study also showed that lecanemab resulted in moderately less decline on measures of cognition and function than taking a placebo.
  • There are potentially serious side effects that need to be considered before beginning the medication. In addition to infusion reactions, there were reports of brain swelling and bleeding (what the drugmakers call ARIA: amyloid related imaging abnormalities.) Three deaths of those in the study have been potentially linked to lecanemab.
  • The drug costs $26,500 per patient annually. As stated above, CMS has not approved payment for the new drug yet, meaning that only those who can afford to pay for it out of pocket will have access to the treatment for now. The Alzheimer’s Association has formally requested that CMS “remove the requirement that Medicare beneficiaries be enrolled in a research study in order to receive coverage of FDA-approved Alzheimer’s treatments.”
  • What you should ask your doctor: Before starting lecanemab, it is advisable to get genetic testing to determine whether the patient has the APOE4 gene, because the study showed that ARIA events were more common in those with that gene. Those on blood thinners should also talk to their doctor about increased risks.

A doctor interviewed by CNN said that lecanemab is another tool that he can add to his toolbox for treating Alzheimer’s disease. Families considering the drug for their loved one should understand that overall the drug’s benefits were modest and weigh that benefit to the potentially serious risks of taking the drug. For some families, the potential to slow down the cognitive decline of their loved ones will be worth that risk.

Just like with cancer, we all wish for a miracle drug or other form of treatment that would offer an instant and complete cure for Alzheimer’s. The reality is more like taking baby steps in the treatment development process, but those small steps can grow into better care and results over time.

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June 11, 2021 · 6:21 pm

Thoughts on the FDA approval of aducanumab to treat Alzheimer’s disease

Alzheimer’s was in the spotlight this week due to the FDA’s controversial decision to approve the drug aducanumab for treatment of the disease. I’ve closely followed the debate and can understand why some hope this is the breakthrough drug we’ve all been waiting for while also agreeing with critics who question the FDA approval process for this drug due to the limited evidence of its effectiveness in trials. There’s also the hefty price tag to consider.

Choosing whether to take a medication or undergo a treatment is a personal decision that should be made with the consult of family and trusted physicians familiar with the individual’s case. Below I’ll go over some general takeaways to consider. If you know of someone who was in the trial I’d love to hear about their experience.

Target treatment group: Aducanumab has so far only been studied in people living with early Alzheimer’s disease and mild cognitive impairment (MCI) due to Alzheimer’s. The FDA approval will allow it to be prescribed to those at any stage of the disease.

How it works: Aducanumab targets the amyloid beta plaque in the brain with the goal of reducing the plaque buildup and slow the rate of cognitive and functional decline.

How effective is it? This is where the main controversy arises. Biogen, the maker of aducanumab, was only able to provide very modest evidence that the drug offers a tangible benefit. “The average degree of improvement on a 0-18 point cognitive scale was just 0.39 points relative to placebo, far smaller than the 1 or 2 point threshold typically used to define a clinically important difference,” according to the two physicians who wrote this Washington Post opinion piece. Trials of the drug were halted in 2019 because an analysis concluded the trials were unlikely to be successful in hitting their goals at completion. But months later, after analyzing a wider set of data and discovering the nominal improvement, Biogen announced it was seeking FDA approval of aducanumab, CNN reported. After an FDA panel voted overwhelmingly to not recommended that drug approval move forward, the FDA eventually greenlighted aducanumab.

The drug was granted Fast Track designation and approved using the accelerated approval pathway, which only requires a “reasonably likely to predict a clinical benefit to patients” and also requires a post-approval trial to verify that the “drug provides the expected clinical benefit.”

What are the side effects? The most common side effects of aducanumab  were “headache, fall, diarrhea, and confusion/delirium/altered mental status/disorientation,” according to the FDA. Brain swelling was also reported by some trial participants.

How expensive is it? Very expensive. The drug is expected to cost $56,000 per year. Part of the expense is in how the drug must be delivered, via infusion every four weeks. There may also be expensive imaging tests required to begin treatment. While insurance companies are expected to pay for some of the cost, it is unclear how much Medicare will reimburse, CNN reported.

What are the general expectations? Those who take aducanumab may see modest improvements in cognitive functioning or see a reduction in the speed of decline in cognitive functioning. It’s important to note that while the drug may remove amyloid plaque from the brain, that doesn’t guarantee an improvement in cognitive functioning. Advocates see it as a treatment with potential, but not a cure. Aducanumab is the first drug to treat Alzheimer’s disease that the FDA has approved since 2003. It has been a long wait, and that is why the drug’s approval has been met with a mixture of hope and skepticism.

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