According to results from the Phase 3 TRAILBLAZER-ALZ 2 study published in JAMA, the monoclonal antibody donanemab significantly slowed cognitive and functional decline in patients with early symptomatic Alzheimer’s disease by approximately 35% at one year compared to placebo. The trial enrolled 1736 patients across 277 research centers in 8 countries. Another monoclonal antibody, Leqembi…
Donanemab slows cognitive decline in early Alzheimer’s patients by 35%
Lilly’s (NYSE:LLY) shares were up more than 5.36% to $425.88 after the company announced upbeat results from the phase 3 TRAILBLAZER-ALZ 2 study, which revealed that the experimental Alzheimer’s drug donanemab significantly slowed cognitive decline in patients with early symptomatic Alzheimer’s disease at 18 months. Almost half of patients, 47%, who received donanemab had no…
FDA hands Lilly’s Alzheimer’s drug donanemab complete response letter
Last year, Lilly’s (NYSE:LLY) Alzheimer’s monoclonal antibody donanemab appeared to be a superior therapy to aducanumab from Biogen (Nasdaq:BIIB) and Eisai (OTCMKTS:ESALY), the first such antibody to win FDA approval. But facing criticism over its decision to grant accelerated approval to aducanumab, FDA has sent Lilly a complete response letter for the accelerated approval submission of…
Lily delays timeline for Alzheimer’s candidate donanemab amidst aducanumab chaos
Eli Lilly (NYSE:LLY) announced it planned to complete the application for donanemab, which received FDA’s Breakthrough Therapy designation as a potential Alzheimer’s treatment last summer. Lilly had initially planned on filing the application for donanemab in the first quarter of the year. LLY shares fell 2.40% to $244.81 after announcing the news. Medicare had announced…
Lilly’s donanemab may outclass aducanumab, but questions remain
FDA’s approval of Biogen’s (NSDQ:BIIB) and Eisai’s (TYO:4523) Alzheimer’s drug aducanumab has resulted in significant gains in those companies’ shares. But Lilly’s (NYSE:LLY) donanemab could be “perhaps better and cheaper,” concluded a recent investor note from Truist. Lilly recently announced that it plans to file for accelerated approval for donanemab in the second half of 2021…
Lilly’s push for accelerated FDA approval of Alzheimer’s drug donanemab
Eli Lilly (NYSE:LLY) has received breakthrough therapy designation from FDA for the investigational antibody donanemab for Alzheimer’s disease. The company plans to file a biologics license application for the drug under the accelerated approval pathway later this year. Like Biogen’s (NSDQ:BIIB) and Eisai’s (TYO:4523) recently approved aducanumab, donanemab is a monoclonal antibody clearing sticky amyloid plaques.…
Biogen moves forward with aducanumab launch plans
Biogen’s (NSDQ:BIIB) Alzheimer’s drug aducanumab seemed to be a potential blockbuster until an FDA advisory committee voiced skepticism in November about the drug. FDA reviewers had previously assessed the drug’s prospects more positively. The company is preparing for the event of an FDA approval of the drug in June. Biogen’s CEO Michel Vounatsos said in…