Washington, Jun 7 (EFE).- The US Food and Drug Administration has approved the use of Aduhelm, a new medication for the direct treatment of Alzheimer’s, the first to directly treat the underlying pathology of this disease.
The FDA said in a statement that this is also the first new treatment that the US administration has approved against the degenerative illness that affects 6.2 million people in the US alone and tens of millions more around the world.
The approval of the drug was accelerated because, as the FDA said, it can likely treat the underlying disease, as opposed to simply managing some of the symptoms associated with Alzheimer’s like anxiety and insomnia.
Aduhelm is a “significant therapeutic advance” in comparison with other treatments in reducing clumps of beta-amyloid protein plaque in the brain, which is a sign of the disease, and thus it is considered “reasonable” that it provides an important benefit for Alzheimer’s sufferers.
The anti-amyloid agent aducanumab, the scientific name for Aduhelm, is made from living cells and administered as an infusion every four weeks. It was developed by Biogen and Japan’s Eisai Company.
Although Aduhelm doesn’t reverse the mental decline associated with Alzheimer’s, one study found that it slows it.
As with virtually all medications, the FDA said there appear to be certain side effects, in particular including inflammation that disappears over time but it can also cause headaches, dizziness or nausea, as well as hypersensitivity reactions such as hives.
The FDA requires Biogen to carry out a broader follow-up study to confirm the benefits of the drug for Alzheimer’s patients, and if the study does not confirm its effectiveness the agency could remove it from the market.
Although Biogen has not yet revealed what the price of Aduhelm will be, some analysts estimate that it could cost between $30,000 and $50,000 for one year’s worth of treatment, and this is far above the $2,500 – $8,300 per year price range that a preliminary analysis by one group showed would be a “good value” based on what it called the “small overall health gains” that studies by the pharmaceutical firm suggest it provides.