Did the FDA approve the Alzheimer’s treatment Dr. Sanjay Gupta described and under what brand name?
Executive summary
Dr. Sanjay Gupta described Leqembi (lecanemab) as a newly approved Alzheimer’s therapy; the FDA converted Leqembi from accelerated to traditional approval after a confirmatory trial verified clinical benefit [1]. Separately, the FDA has also approved donanemab for early symptomatic Alzheimer’s under the brand name Kisunla [2] [3].
1. What Dr. Sanjay Gupta said — and which drug that matches
Dr. Gupta has discussed Leqembi in his reporting and analyses as the Alzheimer’s antibody that achieved full approval and was heralded as the first drug shown to slow disease progression; CNN coverage tied Gupta’s reporting to the moment Leqembi received full FDA approval [4]. Independent pieces summarizing Gupta’s public commentary and guest posts also refer to the full FDA approval of lecanemab/Leqembi and its measured clinical effect [5] [4].
2. FDA actions: Leqembi’s conversion to traditional approval
The FDA converted Leqembi (lecanemab-irmb) to traditional approval after a confirmatory Phase 3 trial (CLARITY AD, Study 301) showed verified clinical benefit for adults with early-stage Alzheimer’s disease; the agency noted Leqembi is the first amyloid‑beta-directed antibody to be converted from accelerated to traditional approval [1]. The FDA’s statement specifies initiation should be in patients with mild cognitive impairment or mild dementia — the population studied [1].
3. A second approved antibody: donanemab as Kisunla
In addition to Leqembi, the FDA approved donanemab for early symptomatic Alzheimer’s disease under the brand name Kisunla (donanemab‑azbt); the FDA announcement and Lilly’s press materials state Kisunla is indicated for adults with mild cognitive impairment or mild dementia with confirmed amyloid pathology and is administered by monthly IV infusion [2] [3]. News coverage summarized the approval as the second such anti‑amyloid antibody shown to modestly slow decline [6].
4. What “approved” means in practice — access, label limits and safety
Regulatory approval does not erase limits: Leqembi’s label includes MRI monitoring and ARIA (amyloid‑related imaging abnormalities) warnings; early approvals sparked debate over safety and Medicare coverage, and the FDA emphasized the verified clinical benefit while noting monitoring and safety caveats [1] [7]. Kisunla’s label also carries a boxed warning for risks including brain swelling and bleeding and has since received label updates to recommend gradual titration to lower ARIA‑E risk, underlining ongoing safety management [2] [8] [9].
5. How large are the benefits the FDA relied on?
Regulatory documents and reporting describe modest but statistically significant slowing of clinical decline: Leqembi’s confirmatory trial was judged to verify meaningful benefit [1], and Kisunla’s pivotal trial showed reductions in integrated Alzheimer’s scales and, in some subgroups, slowing of decline by about one‑third compared with placebo [2] [3] [6]. News reports summarized Kisunla as slowing progression modestly and noted trial‑measured effect sizes [6].
6. Competing viewpoints and the context of controversy
Some scientists and commentators welcomed Leqembi and Kisunla as the first disease‑modifying options for early Alzheimer’s, while others cautioned that benefits are modest, safety risks (ARIA) are nontrivial, and reimbursement and real‑world access remain unsettled — debates reflected in FDA briefings and science reporting [1] [7]. The NIH and clinical reviews place both lecanemab and donanemab among the anti‑amyloid immunotherapies that mark progress but still require more research into optimal use, populations, and combination approaches [10] [11].
7. What sources explicitly confirm and what they do not
Primary FDA communications confirm Leqembi’s conversion to traditional approval and the particulars of the indication and trial basis [1]. The FDA press release and Lilly material explicitly confirm Kisunla (donanemab‑azbt) approval and dosing/label details [2] [3]. Available sources do not mention any specific on‑air quote from Dr. Gupta saying a different brand name than Leqembi for the drug he described; sources tie Gupta’s reporting to Leqembi coverage [4] [5].
8. Bottom line for readers
Dr. Sanjay Gupta reported on Leqembi (lecanemab), whose approval status was upgraded to traditional FDA approval after confirmatory evidence [1] [4]. Separately, the FDA has approved donanemab under the brand Kisunla for early symptomatic Alzheimer’s [2] [3]. Both drugs produced modest slowing of decline in trials and carry safety warnings and monitoring requirements, and broader uptake depends on clinical judgment, safety management, and reimbursement decisions [1] [7] [6].