FDA Approves Biogen's Second Alzheimer's Treatment Under Accelerated Pathway

  • The FDA has approved Biogen Inc's BIIB second Alzheimer's disease treatment, Leqembi (lecanemab-irmb) via the Accelerated Approval pathway.
  • Leqembi is the second of a new category of medications approved for Alzheimer's disease that target the fundamental pathophysiology of the disease.
  • Eisai Co Limited ESALY-partnered lecanemab reduced clinical decline on the global cognitive and functional scale by 27% at 18 months, relative to the placebo, the trial's primary endpoint.
  • In June 2021, Biogen's Aduhelm (aducanumab) became the first Alzheimer's treatment approved since 2003.
  • Though the treatment remained in the controversial zone as it received FDA approval despite the adcomm giving a thumbs down. The company also slashed the price by half a year ago.
  • Lecanemab has, too, witnessed safety concerns. Three deaths have been associated with the treatment.
  • The labeling states that Leqembi should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was studied in clinical trials. 
  • The labeling also states that there are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied.
  • Investors also are waiting to see how the Centers for Medicare and Medicaid Services handles Lecanemab, as medicare declined to broadly cover aducanumab, saying the cognitive benefits were unclear.
  • Price Action: BIIB shares were up 3.57% at $281.28 on the last check Friday before trading halted.
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