FDA Asks for More Data on Lilly's Alzheimer's Drug Candidate

The United States' drug regulatory agency declined to approve a drug from Eli Lilly and Co. (LLY). The stock price of the company dropped by 2.32%.

The company has reported that regulators have requested additional data from clinical testing for Eli Lilly & Co.'s proposed new Alzheimer's disease treatment.

The recent setback could potentially push back the commercial launch of the much-awaited drug by a few months, depending on the decision of the Food and Drug Administration.

On Thursday, the U.S. Food and Drug Administration (FDA) sent a complete-response letter to Eli Lilly and Company in response to their application for accelerated approval of the drug donanemab.

The FDA requested that Lilly provide clinical data from a minimum of 100 participants who had been given the drug for a period of at least 12 months. Lilly responded that they had already submitted the results of a midstage study of donanemab to the FDA, however, the study had fewer than 100 volunteers who had taken the drug for a minimum of 12 months.

Lilly declared that it would collaborate with the FDA to determine the quickest way to make the drug available. The firm is conducting a late-stage study examining donanemab in a larger group of people, and the outcomes are anticipated to be revealed during the second quarter.

The Food and Drug Administration (FDA) suggested that they would need more information from a larger study before they could make a determination, according to Lilly.

Lilly intends to utilize the data they have collected to submit a request to the FDA for the traditional authorization of donanemab sometime during the middle of the year.

Anne White, an executive vice president and president of Lilly's neuroscience business, expressed the company's dedication to collaborating with the FDA to expedite the process of providing this potential medicine to those who require it.

On Friday, the FDA's refusal of Eli Lilly's Alzheimer's medication caused the company's stocks to drop by more than 1% in the morning. In the past few months, investors had been buying the shares in anticipation that the drug could bring in billions of dollars in revenue.

A potential delay in FDA approval of the drug may not have a major effect on Lilly's financial outlook. Lilly has stated that even if the drug were to be approved quickly in early 2023, initial sales would be limited due to a Medicare policy that restricts coverage of new Alzheimer's drugs.

Advocates for Alzheimer's have requested that the Centers for Medicare and Medicaid Services reevaluate their policy, but if the agency decides to do so, it could take several months for the change to be implemented.

David Risinger, an analyst from SVB Securities, stated in a research note that the FDA's rejection of donanemab does not alter his opinion of the drug, as its sales potential is contingent on the results of a larger, late-stage study, which are anticipated to be released in the second quarter.

The Indianapolis-based pharmaceutical company, Lilly, has stated that their financial forecast for 2023 will remain unchanged.

Lilly had been expecting a quick FDA approval of donanemab at the beginning of this year. However, the filing of a standard drug application has caused the FDA decision to be delayed until 2024, as the FDA usually takes six to 10 months to review new drug applications.

The Food and Drug Administration (FDA) may grant accelerated approval to a drug that treats a serious condition, allowing it to enter the market earlier than usual. This type of approval is based on a smaller set of clinical evidence than what is typically required for a standard drug approval.

Recently, the FDA has granted early approval to a new Alzheimer's drug developed by Eisai Co. and Biogen Inc. This marks the agency's approval of yet another therapy for the condition.

The Food and Drug Administration (FDA) has given conditional approval to a medication known as lecanemab or Leqembi, which was found to reduce the amount of amyloid, a sticky substance, in the brains of individuals with early-stage Alzheimer's disease in an initial study.

In its application, Lilly requested the FDA to grant accelerated approval of donanemab based on evidence that the drug could reduce the amount of amyloid present, which is thought to be a factor in Alzheimer's disease.

A midstage study involving over 250 participants revealed that the drug was able to reduce cognitive and functional decline when compared to a placebo.

Lilly reported that a number of participants in the midstage study were able to discontinue the medication after only six months due to the drug's effectiveness in eliminating amyloid plaque from their brains. Consequently, fewer than 100 of the patients in the study had to take the drug for a full year.