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.

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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…

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