FDA Grants Approval for Alzheimer’s Drug
On June 7, 2021, the United States Food and Drug Administration (FDA) granted accelerated approval for Aduhelm, a drug that can be used to treat Alzheimer’s disease. This drug is a monthly infusion meant to reduce amyloid protein clumps in the brain, which are a common marker of Alzheimer’s disease. This is the first new treatment approved for Alzheimer’s since 2003.
In order to evaluate whether Aduhelm was effective, researchers conducted three separate studies with 3,482 patients. Common side effects of Aduhelm can include temporary swelling in areas of the brain that usually resolves over time, headache, diarrhea, falls, and confusion or delirium.
In order for a drug such as Aduhelm to be granted accelerated approval, it must be considered reasonably likely to predict a clinical benefit to patients and a post-approval trial to verify these results is required. If post-approval trials fail to verify the drug’s clinical benefit, the FDA could withdraw its approval of Aduhelm.
Despite the FDA’s fast-track approval, there has been controversy surrounding the drug. Last year, an FDA advisory panel urged the agency to reject the drug because clinical trials did not necessarily prove it to be beneficial. While studies did show that the drug reduced plaque, the reduction in plaque did not necessarily show changes in how the disease progressed. At an estimated cost of $56,000 per year, many doctors are unwilling to recommend that their patients start taking Aduhelm until further research is completed.
Nevertheless, the fact that progress is being made toward the treatment of Alzheimer’s disease for the first time in almost 20 years is an encouraging step in the right direction.
Ask The Attorney
Client: I had a will prepared in another state. Is it valid in Virginia?
Hook law Center: If your will was properly prepared in another state, it is probably valid in Virginia. However, your family may be required to obtain affidavits from witnesses to the original will and you may have inapplicable or inadequate provisions. It would be wise to have your will reviewed by an attorney.
Hook Law Center: Jolene, what can you tell us about this year’s cicadas?
Jolene: This summer is the first time in 17 years that “Brood X” cicadas will emerge in several states. Unlike annual cicadas, these periodical cicadas live underground for most of their lives and emerge every 17 years to mate. “Brood X” has appeared in 15 states as well as D.C., and the pesky insects have already caused quite a commotion. On Monday, June 7, cicadas caused a car crash in Cincinnati after flying through the open window of a car and hitting the driver in the face, causing him to crash into a utility pole. A White House press charter plane had mechanical issues after being plagued with cicadas, and a PGA golf tournament was disrupted as well.
The cicadas are expected to go back underground at the end of June, reemerging sometime in 2038.