The FDA has approved a new autoinjector formulation for lecanemab (Leqembi; Eisai), an antiamyloid therapy indicated for patients with early-stage Alzheimer disease (AD) and mild cognitive impairment (MCI) from AD. With this decision, the subcutaneous autoinjector (SC-AI) becomes the first-ever at-home, self-administered option for ongoing AD treatment.
Branded as Leqembi Iqlik,the subcutaneous autoinjector contains 360 mg/1.8 mL (200 mg/mL), administered over approximately 15 seconds. Its specific indication is for maintenance dosing to treat AD in patients with MCI or the mild dementia stage of the disease.
Results showed that after 6 months, patients receiving SC-AI achieved 14% greater amyloid plaque clearance compared with IV dosing. Pharmacokinetic analyses confirmed that subcutaneous administration achieved drug exposure within accepted bioequivalence limits (80%–125%),thus supporting Eisai’s selection of a dose that delivers efficacy comparable to the IV formulation while offering patients a more convenient treatment option.
That’s a big step forward . The FDA approval of the Lecanemab autoinjector (Leqembi Iqlik) which means Alzheimer’s patients can now continue treatment at home instead of regular hospital visits.
Alzheimer is a localized cerebral amyloidosis in which amyloid beta get accumulated and form plaques which can trigger inflammation , oxidative stress and even form tau protein or neurofibrillary tangle in hippocampus and cerebral cortex mainly. Lecanemab is a monoclonal antibody , which target amyloid beta protofibril which are soluble and get excreted out of body and prevent plaque formation. It can stop Alzheimer from progressing , but cannot reverse it. So it will effective in early diagnosed Alzheimer or people with genetic predisposition.
It is a positive shift from just symptomatic treatment ( with Donepezil , Memantine ) to disease modifying drugs along with drug like Aducanumab , Lecanemab.
But it do have some side effects like swelling in brain , microhemorrhages and headache.
People can use the pen to give themselves weekly maintenance doses of the drug. Lecanemab, made by Eisai and Biogen, was originally approved as an IV infusion that took about an hour and required patients to visit infusion clinics twice a month. The at-home version is approved as a maintenance therapy that people can give themselves after they have finished a course of the infusion treatment.Self-testing and self-treating are becoming bigger trends in medicine, and now, you can conduct part of your treatment at home by yourself if you have Alzheimer’s disease.
Great share! At-home lecanemab autoinjector offers Alzheimer’s patients convenient, effective treatment with comparable efficacy to traditional IV dosing.
. The FDA approval of the Lecanemab autoinjector (Leqembi Iqlik) which means Alzheimer’s patients can now continue treatment at home instead of regular hospital visits.