As of today, there’s no proven cure yet for Alzheimer’s disease.
Alzheimer’s is a degenerative brain disease caused by multiple brain changes due to cell damage. It is one of the most common causes of dementia. Today, at least 50 million people across the globe are believed to be living with Alzheimer’s disease.
In the US alone, over 5.8 million people suffer from Alzheimer’s disease. It is predicted that by 2050, 13.8 million Americans aged 65 above could be living with Alzheimer’s unless scientists develop new treatments to prevent or cure.
Eli Lilly and Co. (LLY.N) announced on June 24, 2021, that it would seek accelerated approval from the USFDA for its Alzheimer’s candidate. It happened weeks after a rival drug from Biogen Inc. (BIIB.O) won the agency’s support for a similar regulatory pathway. Following the announcement, Lilly’s shares rose to over 8%, while Biogen went down to nearly 5%.
A drug developed by Biogen called Aduhelm was approved under the FDA’s accelerated approval program. The said program permits certain medicines on the market earlier if proven based on pieces of evidence to be beneficial to patients. However, such approvals are still subject to follow-up studies to verify if the drugs work as intended.
About Eli Lilly and Co.
Eli Lilly and Company is a US-based drug manufacturing company. The company develops several human pharmaceutical product sectors. Established in 1876 and was named after Colonel Eli Lilly, a pharmaceutical chemist, and veteran of the American Civil War.
Eli Lilly’s main office is located in Indianapolis, Indiana. Eli Lilly has offices in 18 counties, but their products are sold in approximately 125 countries. It is the first company to mass-produce the polio vaccine and insulin. It is currently the biggest manufacturer of psychiatric medications and produces Prozac, Dolophine, Cymbalta, and Zyprexa.
USFDA criticized for the approval of Biogen’s Aduhelm
USFDA faced rising criticism over the mentioned Alzheimer’s drug approval. Based on a report from Reuters, Biogen’s Aduhelm was approved based on the evidence that it can reduce brain plaques, a possible contributing cause of Alzheimer’s. There was no proof that it slowed down the progression of the disease. In addition, experts said that the regulatory agency ignored the recommendations of its third-party advisors, who believed that Biogen did not provide enough evidence of Aduhelm’s benefit.
Earlier, Biogen claimed that one of the two vital studies revealed a significant benefit in slowing cognitive and functional deterioration amongst Alzheimer’s patients. Sad to say, the second trial showed that the drug only helped patients who were provided with a high dose for at least 10 months.
Eli Lilly’s Donanemab Clinical Trial
The company said they would apply for USFDA approval based on data from a mid-stage, 272-patient clinical trial, which showed that Donanemab slowed the rate of decline in patients’ cognition and function. Like Adulhelm, the candidate from Eli Lilly, Donanemab, is designed to remove bunches of a hallmark Alzheimer’s protein known as beta-amyloid from the brain.
According to experts and analysts, the findings help prove that plaques play an important role in Alzheimer’s. Donanemab targets a type of beta-amyloid called N3pG which can be cleared, allowing precise treatment of patients until their plaques are removed.
Patients who participated in the study stopped receiving monthly infusions of the drug. They were also switched to placebo once their brain plaques achieved levels witnessed in healthy persons. Accordingly, the process took just a few months for some patients.
Mr. Daniel Skovronsky, Lilly’s chief scientific officer, told Reuters that the study illustrates that the presence of amyloid is an essential factor in the progression of Alzheimer’s disease. He also said that the results show that additional strategies are needed to fight the disease ultimately.
Alzheimer’s is not just memory loss. Alzheimer’s is fatal. Eli Lilly said that the mid-stage trial met its primary goal of proving a significant change. The result of the secondary objectives of the clinical trial measured that cognition and function were positive, though not all of them reached statistical significance.
Current Studies on the Drug
Eli Lilly continues studying the drug with a second trial among 500 patients.
Lilly and Biogen are among the large pharmaceutical companies finding a cure for Alzheimer’s disease. Any Alzheimer’s treatment that can halt the progression of the disease is a multi-billion-dollar product. Sadly, the field is beset by more than a hundred failures, including those that target beta-amyloid.
Eli Lilly begins a quick USFDA review for Alzheimer’s candidate drug, Donanemab, and a head-to-head test against its rival Aduhelm. The search for medicine against Alzheimer’s continued as Eli Lilly secured an accelerated FDA review for Donanemab.
Despite issues of Biogen, Eli Lilly is hopeful that they will succeed in this endeavor. Along with the rolling submission news, the Indianapolis Big Pharma also presented plans of a crucial Phase 3 trial known as Trailblazer-Alz 4 as a one-on-one test comparing Donanemab to Aduhelm. The project aims to assess who among the candidates is superior in removing brain amyloid plaque in the early-onset Alzheimer’s disease.
Initial results from the study would be available in the second half of 2020, according to Mr. Skovronsky. The application will commence this year and have continued monitoring by the market and the FDA. If the Donanemab beats Aduhelm and Eli Lilly can be keen on pricing, they can succeed in a more market-ready Alzheimer’s treatment.
What’s Next for Eli Lilly and Co.?
The head-to-head trial of the two competing firms may not arrive at a critical question encountered by all the companies working on Alzheimer’s rehabilitation. Do they work? Mr. Skovronsky said the test would be simple, focusing on removing plaque on the brain instead of clinical efficacy.
If we trust that plaque lowering is the appropriate alternative, then this question would be answered in the next 12-18 months, Mr. Skovronsky concluded.
