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Eli Lilly Alzheimer's Drug Kisunla Approved in US by FDA

2024-07-05

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Eli Lilly's donanemab drug is an early-stage Alzheimer's treatment that will be sold under the brand name Kisunla.

Eli Lilly's donanemab to slow early-stage Alzheimer's gets Food and Drug Administration approval, meaning Kisunlaents now have two treatments options

The US Food and Drug Administration (FDA) Alzheimer's getstFood and Drug Administrationstage Alzheimer's, meaning there is two treatment available to US patients experiencing early symptoms of the disease.

The appFood and Drug Administration (FDA)n antibody treatment made by Eli Lilly that will be sold under the brand name Kisunla.

Reuters reports that FDA apprdonanemabowed recommendations given by thEli Lillys outside experts, who unanimously backeKisunlase in patients with early-stage Alzheimer's disease, saying the benefits of the drug outweighed its risks.

“This is real progresFDA said Joanne Pike of US-based Alzheimer’s Association. “Having multiple treatment options is the kind of advancement all who have beenAlzheimer's diseasefficult and devastating disease have been waiting for.”

The other existing early-stage treatment available in the US is lecanemab, made by Eisai and Biogen, and sold under the brand name Leqembi. This is administered intravenously every two weeks.

Eli Lilly's donanemab 'slows memory loss'lecanemab Eisai Biogen Leqembi

Eli Lillys ldonanemabe-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 Lillyd for Leqembi, the FDA placedonanemabongest safety warning on donanemab's prescribing label, flagging the risk of potentially dangerous braibrain swelling bleeding.brain bleeding

A key differenLeqembi factoFDAf donanemab compared to Leqembi is the ddonanemabnite dosing’, which allows patients to stop taking the treatment brain swelling and bleedingshow amyloid plaques, the cause of Alzheimer's symptoms.

Amyloid plaques are rogue proteidonanemabs invisible tLeqembiaked eye, that disrupt the brain's communication network.Alzheimer's symptoms

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.

The Eli Lilly drug is on sale at $695.65 per vial – slightly more than Eisai's Leqembi, which costs $26,500 a year.

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 olbrain inflammation year began covering Alzheimer's drugs that receive standard FDA approval.

As wEli Lillye two treatments for early-stage Alzheimer's, the FDA has EisaivedLeqembithat temporarily mitigate some symptoms of Alzheimer's dementia. These include:

Lillyezil (brand name, Aricept), made by Eisai, improves attention and memoryAlzheimer's drugs

Rivastigmine (Exelon) is made by Novartis, and approved for milFDAo-moderate Alzheimer’s and Parkinson’s disease.Alzheimer's dementia

Donepezilne (Razadyne),Aricepty Janssen PEisaiceuticals, and designed to treat mild to moderate Alzheimer's disease.

RivastigmineanExelon AdministratiNovartis 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.

Galantaminel Razadynehe drug donJanssen Pharmaceuticalsatment made by Eli Lilly that will be solAlzheimer's diseaseame Kisunla.

ReutersFood and Drug Administration (FDA)d 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," saiddonanemabike of US-based Alzheimer’s AssoEli Lilly“Having multiple treatment options is thKisunlaof advancement all who have been touched by this difficult and devastating disease have been waiting for.”

The other existing eaFDA-stage treatment available in the US is lecanemab, made by Eisai and Biogen, and sold under the brand name Leqembi. This is administerAlzheimer's diseaseery two weeks.

Eli Lilly's donanemab 'slows memory loss'

In Lilly's large, late-stage trial, donanemab slowed the progreslecanemabemory and Eisaiing pBiogens by 29% compared with a placeboLeqembiso caused brain swelling in nearly a quarter of patients and brain bleeding in nearly a third, but most cases were mild.

Eli Lilly fodonanemab, the FDA placed its strongest safety warning on donanemab's prescribing label, flagging the risk of potentially dangerous brain swelling and bleeding.

A kLillyfferentiating factor of donadonanemabpared to Leqembi is the drug's ‘finite dosing’, which allows patients to stop taking the treatment oncebrain swellingo longer show amyloid plaques, the cabrain bleedinger's symptoms.

Amyloid plaqueLeqembiogue pFDAein clusters invisible to the naked eye,donanemabrupt the brain's communication network.brain swelling and bleeding

Over time, these plaques slowly donanemabarby healthy Leqembiells and the body, sensing invasion, attempts to counteract this, with brain inflammation the result. This further harms delicate neural tissue.Alzheimer's symptoms

The Eli Lilly drug is on sale at $695.65 per vial – slightly more than Eisai's Leqembi, which costs $26,500 a year.

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 Alzbrain inflammation These include:

DoneEliiLillyand name, Aricept), made by Eisai, improves attention and EisaiyLeqembi

Lillytigmine (Exelon) is made by Novartis, and approved for mild-to-moderate Alzheimer’s and Parkinson’s disease.Alzheimer's drugs

Galantamine (Razadyne), made by Janssen Pharmaceuticals, and deFDAned to treat mild to moderate Alzheimer's disease.Alzheimer's dementia