On Friday, January 6, the US Food and Drug Administration gave accelerated approval to Leqembi™ (lecanemab – irmb), a drug developed by Eisai in partnership with Biogen, for the treatment of Alzheimer’s disease. The drug is approved for use by people with Mild Cognitive Impairment (MCI) or early stage Alzheimer’s disease who also have evidence of amyloid plaque buildup as confirmed by an imaging scan. This is the same population that was studied in the clinical trial which showed that the drug slowed the rate of cognitive decline by 27% as compared to the placebo group in the 18 month-study and also reduced the levels of beta-amyloid in the brain. Eisai plans to submit data from an additional clinical trial to seek full final approval from the FDA.
Leqembi™ is administered by intravenous infusion every two weeks. In addition, the FDA’s approval mandates that those taking the drug undergo three additional scans during the first 14 weeks of treatment to monitor for the potential of serious brain swelling or bleeding.
“The FDA’s approval of Leqembi™ is exciting news for those impacted by this life changing disease,” said Ken Zaentz, President and CEO of Alzheimer’s New Jersey®. “While not a cure and not a drug for every person with Alzheimer’s, it offers real hope for all families that science can intervene to offer a meaningful difference for persons with Alzheimer’s and their caregivers. The approval of this drug for those with MCI and early stage Alzheimer’s also emphasizes the importance of clinical trial enrollment, early diagnosis and ongoing physician education related to both of these areas as well as in identifying those who will most benefit from this new treatment option,” Zaentz continued.
“On the heels of the FDA approval, Alzheimer’s New Jersey® joins with many partner organizations in urging the Centers for Medicare and Medicaid Services (CMS) to quickly move forward and reverse its 2022 decision limiting coverage to this entire class of drugs and provide full national coverage for Leqembi™ so that it is accessible as a treatment option for those who stand to benefit,” said Zaentz.
For additional information, please contact the Alzheimer’s New Jersey helpline at 888-280-6055.
