Alzheimer’s disease is a neurodegenerative condition and is the cause of 60 to 70 percent case of dementia. The Food and Drug Administration (FDA) has now approved the use of the drug known as lecanemab that slows down the progression of the disease. A panel of experts has described the effects of the drug as robust, clear and consistent post clinical trials. The drug is sold under the brand name Leqembi, which would get a complete FDA approval by July 6, 2023. A complete approval would prove to be a ray of hope for 6.5 million people who are affected by Alzheimer’s disease.
However, despite receiving a complete approval, there are still hurdles that need to be addressed. Even if the drug gets approved through the accelerated approval process, which is the Centres for Medical Care and Medicaid Services, it will only cover the drug for the patients who get enrolled in a national registry. Such a registry does not exist yet and it is still unknown how or when the patients are going to be enrolled. It is also not known how the patients, doctors or caregivers are going to enroll for the drug.
The problem has been criticized by the people at the Alzheimer’s Association. The association has released a statement that has expressed that medicare is expected to be a guarantee for the Americans. The statement added that the Centres for Medicare and Medicaid Services should set up and provide Medicare access on the day the FDA approves the drug. The association has also expressed that people who suffer from the disease, deserve an access to the drug that has been approved, without barriers.
On the other hand, the CMS is seeking more information about lecanemab, while the Department of Veteran Association has decided to use it for the patients in the VA system. It was noticed in the clinical trials that people who had mild cognitive decline and took lecanemab had a 27 percent slower decline in cognitive abilities.
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