Investigation Discloses Safety, Efficacy Concerns About Eli Lilly's Donanemab

(RTTNews) - An investigation, published in the journal The BMJ, found that the newly U.S. Food & Drug Administration-approved donanemab is linked to multiple patient deaths during trials, design flaws, and financial ties of panelists involved in the drug's approval, raising concerns about the safety and efficacy of the Alzheimer's drug.

Donanemab, manufactured by Eli Lilly (LLY), is the latest in a new class of anti-amyloid drugs that deliver antibodies to target beta-amyloid, a protein linked to Alzheimer's disease.

Initially, the FDA denied the drug's approval in January 2023, citing a "high rate" of missing data and concerns about the drug's long-term safety. Officials reported a higher number of treatment discontinuations due to adverse events, such as brain hemorrhage and swelling, among donanemab patients compared to placebo.

In response, the drug manufacturer hired an external company "to search publicly available records and databases, social media, and traditional media" to obtain the missing data. The search found two additional deaths among patients in the donanemab arm and five deaths in the placebo arm.

However, Steven Goodman, a clinical trial design expert at Stanford University, expressed skepticism about the reliability of the data without transparency on the outside company's methods.

"There was also no information on health outcomes in those patients other than death, nor the causes of the deaths," Goodman said, noting that the "failure to formally follow patients who stopped treatment was a significant design flaw, particularly when that discontinuation was partly due to adverse drug effects."

The report further revealed that seven of the eight FDA-appointed doctors, who reviewed donanemab, received direct payments from drug companies, with some receiving up to $62,000 for consulting and speaking fees, and up to $10.5 million in research grants from 2017 to 2023.

The report comes as the Alzheimer's drug is awaiting approval in the UK, raising concerns about its chances of receiving regulatory approval.