Eli Lilly Alzheimer's Drug Kisunla Approved in US by FDA
05 Jul 2024
Drug Approval
Preview
Source: Healthcare Digital
Eli Lilly's treatment to slow early-stage Alzheimer's gets Food and Drug Administration approval, meaning US patients now have two treatments options
The US Food and Drug Administration (FDA) has approved another treatment to slow early-stage Alzheimer's, meaning there is two treatment available to US patients experiencing early symptoms of the disease.
Reuters reports that FDA approval followed recommendations given by the agency's outside experts, who unanimously backed its use in patients with early-stage Alzheimer's disease, saying the benefits of the drug outweighed its risks.
“This is real progress," said Joanne Pike of US-based Alzheimer’s Association. “Having multiple treatment options is the kind of advancement all who have been touched by this difficult and devastating disease have been waiting for.”
In Lilly's large, late-stage trial, donanemab slowed the progression of memory and thinking problems by 29% compared with a placebo. It also caused brain swelling in nearly a quarter of patients and brain bleeding in nearly a third, but most cases were mild.
As it did for Leqembi, the FDA placed its strongest safety warning on donanemab's prescribing label, flagging the risk of potentially dangerous brain swelling and bleeding.
A key differentiating factor of donanemab compared to Leqembi is the drug's ‘finite dosing’, which allows patients to stop taking the treatment once brain scans no longer show amyloid plaques, the cause of Alzheimer's symptoms.
Preview
Source: Healthcare Digital
Amyloid plaques are rogue protein clusters invisible to the naked eye, that disrupt the brain's communication network.
Over time, these plaques slowly poison nearby healthy brain cells and the body, sensing invasion, attempts to counteract this, with brain inflammation the result. This further harms delicate neural tissue.
Lilly's drug is expected to be used mostly by patients enrolled in the US government's Medicare health plan for people age 65 and older. Medicare last year began covering Alzheimer's drugs that receive standard FDA approval.
As well as the two treatments for early-stage Alzheimer's, the FDA has approved drugs that temporarily mitigate some symptoms of Alzheimer's dementia. These include:
Rivastigmine (Exelon) is made by Novartis, and approved for mild-to-moderate Alzheimer’s and Parkinson’s disease.
Galantamine (Razadyne), made by Janssen Pharmaceuticals, and designed to treat mild to moderate Alzheimer's disease.
The US Food and Drug Administration (FDA) has approved another treatment to slow early-stage Alzheimer's, meaning there is two treatment available to US patients experiencing early symptoms of the disease.
Reuters reports that FDA approval followed recommendations given by the agency's outside experts, who unanimously backed its use in patients with early-stage Alzheimer's disease, saying the benefits of the drug outweighed its risks.
“This is real progress," said Joanne Pike of US-based Alzheimer’s Association. “Having multiple treatment options is the kind of advancement all who have been touched by this difficult and devastating disease have been waiting for.”
In Lilly's large, late-stage trial, donanemab slowed the progression of memory and thinking problems by 29% compared with a placebo. It also caused brain swelling in nearly a quarter of patients and brain bleeding in nearly a third, but most cases were mild.
As it did for Leqembi, the FDA placed its strongest safety warning on donanemab's prescribing label, flagging the risk of potentially dangerous brain swelling and bleeding.
A key differentiating factor of donanemab compared to Leqembi is the drug's ‘finite dosing’, which allows patients to stop taking the treatment once brain scans no longer show amyloid plaques, the cause of Alzheimer's symptoms.
Preview
Source: Healthcare Digital
Amyloid plaques are rogue protein clusters invisible to the naked eye, that disrupt the brain's communication network.
Over time, these plaques slowly poison nearby healthy brain cells and the body, sensing invasion, attempts to counteract this, with brain inflammation the result. This further harms delicate neural tissue.
Lilly's drug is expected to be used mostly by patients enrolled in the US government's Medicare health plan for people age 65 and older. Medicare last year began covering Alzheimer's drugs that receive standard FDA approval.
As well as the two treatments for early-stage Alzheimer's, the FDA has approved drugs that temporarily mitigate some symptoms of Alzheimer's dementia. These include:
Rivastigmine (Exelon) is made by Novartis, and approved for mild-to-moderate Alzheimer’s and Parkinson’s disease.
Galantamine (Razadyne), made by Janssen Pharmaceuticals, and designed to treat mild to moderate Alzheimer's disease.
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