Eli Lilly’s Breakthrough with Alzheimer’s Drug
The American pharmaceutical company Eli Lilly has achieved a significant milestone with one of its biggest hopes: An advisory panel of the US Food and Drug Administration (FDA) has now unanimously recommended a new Alzheimer’s drug from the company. The panel concluded that the benefits of the drug, called Donanemab, outweigh the associated risks. This decision paves the way for approval in the US by the FDA. While the agency is not required to follow the panel’s recommendation, it typically does so in most cases. Eli Lilly is also working on obtaining approval in other regions such as the EU. CEO Dave Ricks recently stated in an interview with F.A.Z. that he hopes to launch Donanemab worldwide by the end of this year.
If the company receives the necessary approvals, it would have another product in its portfolio with significant revenue potential. Analysts have estimated that Donanemab could generate annual revenues in the billions of dollars. In addition to this, Eli Lilly is also present in the rapidly growing market for diabetes and diet injections and is currently struggling to keep up with demand.
With its products Mounjaro and Zepbound alone, the company reported revenue of $2.3 billion in the first quarter. In April, Eli Lilly broke ground on a new factory in Alzey, Rhineland-Palatinate, where these preparations are to be manufactured. The prospects in this market have significantly contributed to Eli Lilly becoming the most highly valued pharmaceutical company in the world. Since the beginning of the year, the stock price has risen by almost 50%, and the market capitalization is currently over $820 billion.
According to the World Health Organization, more than 30 million people worldwide suffer from Alzheimer’s. However, the disease has proven to be particularly challenging and frustrating for the pharmaceutical industry. There is currently no cure, and many research projects, including those by Eli Lilly, have failed. CEO Ricks stated, „We have been working in this field for 38 years and have invested $8 billion, and to this day, we are empty-handed.“
Donanemab is expected to herald a new era. In clinical trials, the drug has slowed the progression of the disease in patients in the early stages. According to Eli Lilly, cognitive decline did not progress further after one year for 47% of study participants, compared to 29% for patients who received a placebo.
However, the treatment also carries the risk of serious side effects such as brain swelling. Three patients participating in the Donanemab study died. The study results for Donanemab are comparable to Leqembi, an Alzheimer’s drug from the pharmaceutical companies Biogen and Eisai, which received approval in the US last year.