On Monday, June 7, the Food and Drug Administration approved a drug to treat Alzheimer’s developed by Biogen Inc., despite skeptics disapproval since its clinical trial results were uninviting.
This approval marks the first-ever therapy for Alzheimer’s authorized by the FDA since 2003. There has not been any other drugs available before to treat the disease that causes dementia, or memory loss and other brain function impairments.
The Biogen product is initially called aducanumab which if it goes on market would have the brand name of Aduhelm.
The drug is said to prevent the buildup of beta-amyloid plaques in the brain, which cause interruption to neuron communication and eventually will result in Alzheimer’s. This drug is hoped to help slow down the disease process and is recommended for use in patients with early symptoms.
The aducanumab is not for patients who have advanced Alzheimer’s.
Clinical trials for aducanumab has drawn up doubts over its effectiveness.
In the first clinical trials for aducanumab in 2016, the drug was seen working in some patients, capable of reducing levels of plaques. However, Techcrunch added that the results did not demonstrate how people’s cognitive ability may benefit from the treatment.
The FDA then allowed the therapy to proceed with the 3 clinical trials (skipping phase 2, which was meant to determine the level of relevant dosages), which looked at monthly intravenous injections of the drug. Aducanumab could not perform to the primary endpoint of slowing cognitive decline; hence the trials were terminated in 2019.
Filing approval for its drug, Biogen argued that its 2019 trials at least still saw 23% patients demonstrating less cognitive decline, which means it still provides posibility to buy early patients more time away from the brain destroying illness.
“It will take more advances, but it does appear from the science that people, especially at early stages, could be real beneficiaries and that the benefits accumulate over time,” Harry Johns, president and chief executive of the Alzheimer’s Association told The Washington Post.
Given the company’s assertion, the FDA granted the drug permission under the accelerated approval pathway, which allows the agency to authorize a drug for a serious or life-threatening illness if it works at a certain level despite “some uncertainty about the drug’s clinical benefit” may remain.
Under the pathway, study on aducanumab’s benefit would still have to be conducted, and if subsequent data suggest the drug is inefficient, FDA will revise the authorization and remove it from market.
Skeptics of Aduhelm condemn that the drug would come at a high price while giving patients false hope since the clinical trial results did not prove that it is highly efficient.
“The worst thing for people with Alzheimer’s would be to put out a product that doesn’t work,” Aaron Kesselheim, a professor of medicine at Harvard Medical School, who projected that the drug “will be sold at an extremely high price and waste resources that could go to other things.”
Biogen announced that the Aduhelm will cost $56,000 a year. In that, a patient of average weight with mild cognitive impairment or mild dementia will have to pay up to $4,312 for a monthly infusion.
“If the drug does not work as intended, we can take steps to remove it from the market. But hopefully, we will see further evidence of benefit in the clinical trial and as greater numbers of people receive Aduhelm,” the FDA statement reads.