The Food and Drug Administration earlier today announced the approval of the Aduhelm Alzheimer's Drug, a high-profile medication for the disease.
As USA TODAY reported, it is a controversial decision to give the first new drug to slow this memory-robbing disease a go signal in almost 20 years.
The landmark approval by the FDA of Bioigen's aducanumab will require the drug company to perform a post-approval study to observe its efficacy. The company said it is marketing the drug under the name "Aduhelm".
This FDA approval comes amid experts' contradictory recommendation to the FDA's Peripheral and Central Nervous System Drugs Advisory Committee which cited in November last year conflicting results from two main clinical trials, a related Business Insider report said.
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The FDA recently approved the Aduhelm Alzheimer’s drug, which is administered through IV once every four weeks to slow the decline in individuals suffering from mild memory and thinking problem.
Meaningful Therapeutic Benefit
Despite the contradictory recommendations, FDA's Center for Drug Evaluation and Research director, Dr. Patrizia Cavazzoni said in a statement the agency issued that the FDA decided the Aduhelm Alzheimer's drug may offer "meaningful therapeutic benefit" over treatments currently available.
The FDA granted a fast-tracked approval of the drug, a standard procedure to provide earlier access for patients with severe illnesses who have unmet treatment needs.
Despite the lingering uncertainty about the benefit of the drug, Cavazzoni explained, the FDA concluded it met the standard of the agency as the potential benefits outweighed the risks.
Alzheimer's patients' advocacy groups commended the decision of the FDA to approve the Aduhelm Alzheimer's drug, which is administered through IV once every four weeks to slow down thinking problems and mild memory loss.
According to Biogen, the price of Aduhelm would be $4,312 per treatment for an individual of average weight, or about $56,000 each year, before insurance.
Ensuring Access to the Drug, Medicare and Private Insurer
Harry Johns, president and Chief Executive Officer of the Alzheimer's Association, said the association will focus on guaranteeing that eligible patients have access to the drug and Medicare, as well as private insurers to cover both testing and treatment.
Johns said that the FDA approval is the conclusion of years of initiatives to fund studies of new treatments to slow the ill effects of Alzheimer's and other forms of dementia. The Alzheimer's Association estimates that about 6.2 million Americans are suffering from Alzheimer's.
Johns made it clear that the drug "is not a cure." As in the case of so many other illnesses, he explained, the first treatments are imperfect although they can and do make a difference and that's quite meaningful to the families of Alzheimer's patients.
What remains unanswered are thorny questions about how doctors are going to determine if a patient is eligible for the Aduhelm Alzheimer's drug and if patients will require expensive PET scans for the detection of amyloid beta plaque deposits in their brain.
According to Dr. Pierre Tariot, director of the Banner Alzheimer's Institute based in Phoenix, it will take months to know if anybody will pay for medications, the infusions, the PET scans and MRIs that will be needed.
Another consideration is the practitioner who will be trained to reveal the amyloid information to the patients as well as their families.
FDA's approval of the Aduhelm Alzheimer's drug is shown on DW News's YouTube video below:
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