FDA Approves Biogen’s Aduhelm, the First New Drug for Alzheimer’s Disease Since 2003

Burlington, MA, June 7, 2021 – Today marks an important milestone in Alzheimer’s disease research with the approval by the FDA of Aduhelm (aducanumab) from the company Biogen. Aduhelm is the first new drug approved for Alzheimer’s disease by the FDA since 2003 and is the first to attack what is believed to be one of the causes of Alzheimer’s disease, amyloid beta plaques in the brain. Previously- approved drugs only treat the dementia symptoms associated with Alzheimer’s disease but not the underlying disease processes.

While this treatment is not a cure, the clinical trials did show that the disease progress slowed down for people in early stages of the disease. Although the disease did continue to advance for people on Aduhelm, it progressed more slowly than people not on the drug.

Due to some questions about the data, the FDA is requiring Biogen to conduct an additional post-approval clinical trial to verify the drug’s clinical benefit. It should also be noted that there is a common side effect associated with Aduhelm. The drug is known to cause swelling (edema) and/or bleeding (microhemorrhage) in the brain for some patients. These side effects were observed by MRI and the issues were resolved quickly when patients were given a lower dose of the drug or taken off the drug entirely. As such, people of Aduhelm may need to be given periodic MRI to ensure that the drug is safe for them.

WHAT DO WE KNOW ABOUT THE POTENTIAL OF THIS DRUG FOR PEOPLE WITH DOWN SYNDROME?

Unfortunately, to our knowledge, no person with Down syndrome was included in the clinical trials and has never been given Aduhelm. Therefore, we can only speculate as to the efficacy and safety of this drug for people with Down syndrome.

First, we know that Aduhelm attacks amyloid beta plaques in the brain and these plaques are present in people with Down syndrome associated Alzheimer’s disease too. Therefore, we can assume that Aduhelm could be effective in slowing the progression of Down syndrome associated Alzheimer’s disease. However, this efficacy in adults with Down syndrome has not been tested or proven.

Second, we know that microhemorrhage is more common in adults with Down syndrome than in the general population and becomes more frequent with age. So, there is a concern that Aduhelm may further increase the risk of microhemorrhage in adults with Down syndrome. Again, we do not know if this is true since people with Down syndrome have never been on Aduhelm.

At this stage we do not know if this drug is safe or effective for people with Down syndrome. If you feel you or your loved one might benefit from Aduhelm, please discuss this potential treatment with your trusted physician.

WHAT IS NEXT FOR ADUHELM?

Biogen will need to complete another clinical trial of Aduhelm in the general Alzheimer’s population even as they begin to market it in the US. This drug will likely be very expensive so we also need to hear from the Centers for Medicare and Medicaid Services (CMS) to see if the drug will be covered by government insurance. Private insurance companies will probably follow the decision of CMS. If the drug is not covered by insurance, it can still be sold but patients will need to cover the entire cost out of pocket.

Please remember, the approval of Aduhelm today was made possible by thousands of hard-working scientists from all over the world and the people that volunteered selflessly to be in all the previous and current Alzheimer’s clinical trials.

While the approval of Aduhelm is an exciting and important step in Alzheimer’s research, our work is not done. We need to continue to learn more about this devastating disease and bring new and better treatments to patients and families. At LuMind IDSC, we are strongly committed to advancing this research and finding safe and effective treatments specifically for Down syndrome associated Alzheimer’s disease. We will continue to keep you updated as more research is conducted including adults with Down syndrome.