FDA Approves Alzheimer’s disease treatment
On Friday, the Food and Drug Administration granted accelerated approval to Eisai and Biogen’s Alzheimer’s disease treatment. The treatment showed in clinical trials that it can slow the progression of the disease.
After the news was announced on Friday afternoon, U.S.-listed shares of Eisai ESALY, +4.12% rallied 9.4%. At the time of publication, Biogen’s BIIB stock was halted.
According to an Eisai spokesperson, the drug lecanemab has been renamed to Leqembi and will cost $26,500 a year. The FDA said that it is approved for patients with mild cognitive impairment or mild dementia.
“Leqembi’s approval provides new hope to patients with Alzheimer’s disease,” Biogen CEO Christopher Viehbacher said in an emailed statement. “Patients and their caregivers can now consult with their doctors about a new treatment option.”
The FDA has approved the second drug in a category of amyloid plaque-clearing medicines. The drug Aduhelm failed to gain traction in the clinic after its controversial accelerated approval in 2021, but Biogen and Eisai brought that therapy to market.
When there is an unmet need, an accelerated approval is a type of quick approval used to commercialize treatments. Eisai plans to seek full approval of Leqembi early this year.
Biogen’s shares are up 18.5% while Eisai’s stock has gained 18.6% over the past year. Over the past 12 months, the S&P 500 SPX has declined 19.0%, currently sitting at 2.28%.
