The U.S. Food and Drug Administration has given the green light to an at-home starting dose of Leqembi, an Alzheimer’s treatment developed by Eisai and Biogen, opening the door for patients to begin therapy through self-administered or caregiver-administered injections.
The newly approved formulation is delivered under the skin, a significant departure from the previous standard of care, which required patients to receive the drug through intravenous infusions at a clinic. Under the old approach, patients could only switch to a maintenance phase after 18 months of IV treatment.
The injectable version of the drug is being marketed under the name Leqembi IQLIK. The FDA noted that the injection-site version can cause local reactions, such as redness, swelling, rash, pain, or bruising at the spot where the shot is given.
BMO Capital Markets analyst Evan Seigerman suggested the at-home approval could broaden the drug’s reach by making it more convenient for patients, and could give it a competitive edge over Eli Lilly’s Kisunla, a rival Alzheimer’s drug that still requires intravenous infusions.
Leqembi is already approved for adults living with Alzheimer’s disease, a progressive condition that gradually erodes memory, thinking, and the ability to carry out everyday tasks. The drug works by targeting amyloid beta, a protein that accumulates in the brains of people with the disease, forming harmful plaques.
The FDA based its decision on two earlier clinical trials that demonstrated the IV version of Leqembi was effective in patients in the early stages of Alzheimer’s, including those experiencing mild cognitive impairment or mild dementia with confirmed amyloid buildup in the brain. The agency did not require separate large-scale trials for the injectable version, instead relying on data showing it produced comparable results and similar reductions in amyloid plaques as the infused form.
News of the approval pushed Biogen’s stock up 4.5% during afternoon trading on Monday.
