donanemab Archives - Medical Design Sourcing

Phase 3 trial shows donanemab reduces Alzheimer’s symptoms by 35%

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 (lecanemab) recently won FDA approval for Alzheimer’s disease treatment after showing a statistically significant 27% reduction in decline on the Clinical Dementia Rating Scale in trials.

Donanemab is an investigational plaque-clearing antibody similar to lecanemab and aducanumab, which controversially notched FDA approval in 2021 based on its plaque reduction despite inconsistent clinical efficacy data.

A look at TRAILBLAZER-ALZ 2

The Phase 3 TRAILBLAZER-ALZ 2 study demonstrated that donanemab, an investigational drug, significantly slowed cognitive and fun…

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 disease progression one year after treatment began, compared with 29% who did not receive the investigational antibody. Donanemab recipients had a clinical decline of 35% compared to placebo recipients based on the primary outcome measure. The drug group had 40% less decline in the ability to perform activities of daily living.

A potential blockbuster

Donanemab seems likely to win FDA approval given the positive data. In September 2022, UBS projected that donanemab would generate peak risk-adjusted sales of $4.8 billion. But earlier this year, FDA sent Lilly a complete response …

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 donanemab to treat early symptomatic Alzheimer’s disease.

Specifically, the FDA noted that a limited number of patients with at least 12 months of drug exposure data were included in the submission.

LLY shares fell 2.23% to $343.26 in afternoon trading.

The Alzheimer’s Association supports the move

The Alzheimer’s Association released a statement praising FDA’s decision, saying that it appreciated its “methodical process in reviewing treatments for Alzheimer’s disease.”

The association noted that the FDA’…

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 a proposal to limit coverage for monoclonal antibodies targeting amyloid to treat Alzheimer’s disease.

Lilly anticipates data from a confirmatory donanemab in 2023.

According to recent research from Spherix Global Insights, about half of neurologists are skeptical about prescribing monoclonal antibodies targeting amyloid, given the controversy related to Biogen’s aducanumab.

A study published in NEJM in 2021 found that patients with early Alzheimer’s disease who received donanemab had an improved composite score for cognition at 76 weeks compared to placebo.

Lilly’s donanemab could 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 under the accelerated approval pathway. As a result, Truist has pushed its launch assumption up two years to 2023 and raised its sales projections for the amyloid-plaque clearing drug.

Assuming the amyloid hypothesis is valid, donanemab holds promise as a potential disease-modifying therapy. In a Phase 2 trial, the investigational drug appeared to promote roughly twice the plaque clearance at 18 months as aducanumab did. Earlier studies also suggested that donanemab cleared plaque aggressively. The potential cognitive benefits of that clearance, however, remain unclear.

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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 an analyst call today that he expects the antibody drug to sell well given the surging numbers of Alzheimer’s patients in the U.S. and elsewhere. “We anticipate if approved, there will be a large influx of patients,” Vounatsos concluded.

The company has argued that aducanumab slows disease progression in Alzheimer’s patients, which is a feat that no other FDA-approved drug can manage. But critics have argued that the company has failed to demonstrate that the drug is effective and have expressed concern over the drug’s potential to cause amyloi…