The FDA has postponed its decision on Eli Lilly's donanemab, an experimental treatment for early Alzheimer's disease. The drug will now be reviewed by an advisory committee to evaluate its safety and efficacy. This is the second delay for donanemab, which has shown promise in clinical trials but is also associated with potential side effects.
FDA Delays Decision on Eli Lilly's Experimental Alzheimer's Treatment
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The U.S. Food and Drug Administration (FDA) has decided to delay its decision on Eli Lilly's experimental treatment for early Alzheimer's disease. The drug, called donanemab, will now be subject to a meeting of outside experts to discuss its safety and efficacy. This is the second regulatory delay for the drug, as Lilly had previously released clinical trial data showing its effectiveness and safety.
The FDA's decision to convene an advisory committee meeting indicates that the agency is taking its time to thoroughly evaluate the drug before making a decision. Similar meetings have been held for other Alzheimer's drugs before their approval. For example, Eisai and Biogen's Leqembi, which works in a similar manner to donanemab, underwent such a meeting and received standard authorization last year.
Howard Fillit, co-founder of the Alzheimer's Drug Discovery Foundation, sees this move as the FDA doing its due diligence before making the drug available to patients. It is unclear when the advisory committee meeting will take place, but it could be several months before it occurs.
Implications of the FDA's Decision
Lilly had initially expected a decision by the end of last year, but the FDA pushed it back to the first quarter of 2024. The agency stated that it needed more time to review the approval application. Despite the delay, Lilly has confirmed that there is no change to its 2024 financial forecast.
Donanemab is administered via monthly infusion and is designed to clear a sticky protein called amyloid from the brain, which is associated with Alzheimer's disease. However, the drug is also associated with swelling and bleeding in the brain, and three people in the company's trial have died while on the treatment.
The FDA wants the advisory committee to discuss certain unique aspects of the clinical trial used for Lilly's traditional FDA approval request. These aspects include efficacy and safety issues, as well as the implications of assessing patients based on levels of another Alzheimer's-related protein called tau.
Lilly's Response and Hopes for a Quick Decision
Anne White, president of Lilly Neuroscience, expressed surprise at the delay, stating that the news came late in the review process. The company had been prepared to launch the drug. White hopes that the advisory committee meeting will lead to a quick decision by the FDA so that the medicine can be made available to patients as soon as possible.
Alzheimer's disease affects more than 6 million Americans, according to the Alzheimer's Association. Lilly had previously reported that donanemab showed a 22-29% slowing of progression in memory and thinking problems in a large clinical trial. In patients with low-to-medium levels of tau, the drug slowed disease progression by 35.1% compared to placebo.
Analysts predict that donanemab sales will reach $189.6 million in 2024 and rise to $837 million the following year. Lilly's overall revenue forecast for 2024 is $40.4 billion to $41.6 billion, with weight-loss and diabetes drugs being the main drivers.
Conclusion
In conclusion, the FDA's decision to delay the approval of Eli Lilly's experimental Alzheimer's treatment, donanemab, is a result of the agency's commitment to thoroughly evaluating the drug's safety and efficacy. The convening of an advisory committee meeting is a standard procedure for drugs in this category. Lilly remains hopeful that a decision will be made promptly after the meeting so that the drug can be made available to patients who could benefit from it.