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

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.

The approval is for the drug donanemab, an antibody treatment made by Eli Lilly that will be sold under the brand name Kisunla.

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.”

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'

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.

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.

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 Alzheimer's dementia. These include:

• Donepezil (brand name, Aricept), made by Eisai, improves attention and memory 
• 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.