United States: In a breakthrough development, the Food and Drug Administration (FDA) on Tuesday approved Eli Lilly’s Alzheimer’s drug donanemab, which allowed the expansion of limited treatment alternatives that were available for the mind-wasting disease in the United States.
The agency has given its approval for the treatment, which would be sold under the brand name Kisunla, being utilized for those adults who experience early symptomatic Alzheimer’s disease, as per the company.
The US and the Alzheimer’s
As per the reports from the Alzheimer’s Association, it is showed that almost seven million Americans suffer from such a condition, which happens to be the fifth-foremost cause of death among adults of age above 65.
Moreover, by the onset of 2050, that group has been envisioned to grow to nearly thirteen million in the US. This would be seen as a long-awaited win that Eli Lilly gained for donanemab, which faces several hurdles in its path toward being seen in the market, as CNBC reported.
Last year, FDA had rejected the drug owing to an insufficient presence of data, which was followed by a surprising delay in March.
However, earlier this month, a recommendation of an advisory panel to the agency stated the full approval of the drug treatment, mentioning that its benefits are way more numerous than its side effects.
Competition to Donanemab
Now, once Donanemab visits the market, it would have to face head-to-head competition with other treatments, such as Biogen and its Japanese partner Eisai called Leqembi, which also won approval last summer.
Both Donanemab and Leqembi are landmark treatments for Alzheimer’s after thirty years of constant failure in developing medicines that could fight such a fatal disease.
Moreover, both of the drugs are monoclonal antibodies that effectively target toxic plaques inside the brain called amyloid, said to be a central figure in Alzheimer’s, to stagnate the progression of the disease inside those which show an early stage of the disease, as CNBC reported.
About the cost of the drug
According to Eli Lily, the drug is said to have been administered through monthly infusions and would cost almost USD 12,522 for a six-month course, USD 32,000 for 12 months, and USD 48,696 for an 18-month course.
Moreover, as per the company’s statement, Medicare would be covering and reimbursing the eligible patients.