US drug regulators have rejected Eli Lilly & Co.’s proposed new Alzheimer’s disease treatment, saying they need more data from clinical trials, according to the company.
The setback could delay a possible commercial introduction of the long-awaited drug by at least several months, if the Food and Drug Administration finally decides to approve it.
The FDA has issued a so-called full response letter to Lilly for the company’s request for fast-track FDA approval of the drug, called donanemab, Lilly said Thursday.
The FDA asked Lilly to provide clinical data on at least 100 study subjects who received a minimum of 12 months of treatment with the drug. Lilly said she had previously submitted to the FDA the results of a mid-stage study of donanemab in which fewer than 100 volunteers took at least 12 months of the drug.
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Lilly said it would work with the FDA to evaluate the fastest route to bring the drug to market. The company is conducting a late-stage study testing donanemab in more subjects, with results expected in the second quarter.
The FDA indicated that it would likely need data from this larger study to make a decision, Lilly said.
Based on that data, Lilly plans to submit an application to the FDA for traditional approval of donanemab by mid-year.
“We are committed to working with the FDA to ensure the fastest path possible to get this potential drug to patients who need it,” said Anne White, Lilly’s executive vice president and president of Lilly’s neuroscience business.
The FDA’s rejection of Lilly’s Alzheimer’s drug sent shares of the company down more than 1% in early trading on Friday. Investors had bid on them in recent months, partly because of expectations that the drug could generate multi-million dollar sales.
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A delay in the drug’s potential FDA approval might not have much of an impact on Lilly’s financial prospects. Lilly has said that even if it were to receive expedited approval for the drug in early 2023, initial sales would be modest due to a Medicare policy that limits coverage of new Alzheimer’s drugs.
Alzheimer’s disease advocates have called on the Centers for Medicare and Medicaid Services to reconsider its policy, but if the agency decides to do so, any change is likely to take several months.
SVB Securities analyst David Risinger said in a research note that the FDA’s rejection does not change its view on donanemab, because its sales prospects depend on the outcome of the largest late-stage study, the results of which are expected in the second trimester.
Indianapolis-based Lilly said it will not change its financial forecast for 2023.
Lilly was hoping for an accelerated approval of donanemab by the FDA earlier this year. Now, a midyear submission of a standard drug application means an FDA decision could be delayed until 2024, based on the FDA’s typical timeframes of taking six to 10 months to review new drug applications.
The FDA sometimes grants expedited approval to allow a drug that treats a serious condition to enter the market early. The FDA can issue accelerated approval for a new drug based on a more limited set of clinical evidence than a standard drug approval.
The agency has recently approved another Alzheimer’s therapy. Earlier this month, the FDA gave early approval of a new Alzheimer’s drug from Eisai Co. and Biogen Inc.
The FDA granted conditional approval to the drug, called lecanemab or Leqembi, based on a preliminary study that found it reduced levels of a sticky substance called amyloid in the brains of people with early-stage Alzheimer’s.
In his case, Lilly had applied to the FDA for accelerated approval of donanemab based on evidence that the drug helped reduce the volume of amyloid, which is believed to be a cause of Alzheimer’s.
The mid-stage study of more than 250 patients also found that the drug slowed cognitive and functional decline compared with a placebo.
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Lilly said that many of the subjects in the mid-stage study were able to stop taking the drug as early as six months after the start of treatment because it cleared amyloid plaque from their brains quickly. As a result, fewer than 100 of these patients had 12 months of treatment in the study.