The results support full approval of lecanemab in early AD, and provide support for the amyloid therapeutic hypothesis (and for the FDA accelerated approval of aducanumab on the basis of amyloid reduction). It may make some patients ineligible for treatment. That drug won FDA approval but then struggled after Medicare limited coverage of the treatment. Could donanemab be the next great hope? The FDA should announce an accelerated approval decision on Lilly's donanemab in January 2023 as well. We review the drugs in current clinical trials for AD. Studies a U.S. FDA-regulated Drug Product: Yes: Though Aduhelm gained FDA accelerated approval in June 2021, Lillys donanemab rounds out the slate of amyloid-targeting antibodies with Phase III results for the 1,800 patient TRAILBLAZER-ALZ 2 study (NCT04437511) expected in Q2 of 2023. Called Aduhelm, the drug controversially won FDA approval last summer despite conflicting results in clinical testing. Brain swelling and inflammation is a common side effect among plaque-clearing drugs. Since then, Aduhelm has earned negligible revenue amid fierce pushback from both doctors and insurers. This potential law is important for two major reasons. The U.S. Medicare program for Lilly said Thursday that it will seek approval for donanemab based on data from a mid-stage clinical study of the drug involving 272 patients. Aducanumab is a drug that has been developed as a potential treatment for Alzheimers disease. Infectious Disease. It was granted FDA breakthrough device status in early 2022. Lilly submitted a licensing application in October 2021, under the same accelerated approval pathway used for aducanumab, with rolling submission of trial data (press release). Biogens aduhelm was the first approved drug, Eisai/Biogens lecanemab may be the first one to have shown slowing of cognitive decline, donanemab may be the second to do so. First, note that Eli Lilly initiated a rolling submission to the U.S. Food and Drug Administration (FDA) for accelerated approval for donanemab in treating early AD in late 2021. Lilly said it remained confident in its donanemab development programme. A Study of Donanemab (LY3002813) in Participants With Early Alzheimer's Disease (TRAILBLAZER-ALZ 2) Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Success with lecanemab would help Biogen recover from its disastrous attempts to sell its first Alzheimers drug. Association of Donanemab Treatment With Exploratory Plasma Biomarkers in Early Symptomatic Alzheimer Disease. Lilly expects a decision from the FDA on donanemab in early 2023, which would be close to when data will be available from its late-stage study, Chief Scientific Officer Daniel Skovronsky said. This blood test is different because it is a preventative diagnostic. Results of a key late-stage trial testing the drug are anticipated by mid-2023. FDA Approval Under Consideration. That means that they are fast tracked in their approval process by being able to conduct clinical trials faster and share their information with the FDA quicker. Lilly to seek FDA approval for new Alzheimer's drug. 3 , 4 , 5 Additional new treatments for AD may become available in the foreseeable future. The attention is now on other Phase 3 drugs such as Eisai and Biogen's lecanemab (an FDA decision is expected in January ) and Lillys donanemab.. A 2021 review identified 143 agents in 172 clinical trials on AD listed in the www.clinicaltrials.gov database, of which 83.2% were putatively disease modifying drugs, 9.8% cognitive enhancers and 6.9% for Find out more about the drug, its path to approval in the US, and what it means for people with dementia in the UK. Gantenerumab? INDIANAPOLIS, June 24, 2021 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for donanemab, Eli Lilly and Company's (NYSE: LLY) investigational antibody therapy for Alzheimer's disease (AD). The U.S. Medicare program for The Breakthrough Therapy designation aims to expedite the development and review of drugs that Even if donanemab earns accelerated approval, Eli Lilly will still have to conduct a study to confirm that it's safe and effective. However, if the FDA fails to approve donanemab, Eli Lillys stock value should drop to the low to mid 200s. Axsome Therapeutics : The company just received FDA approval on a treatment for major depressive disorder in adults. Jun 25, 2021. In June 2021, the FDA granted donanemab Breakthrough Therapy designation, to speed development and review. The FDA has, thus far, approved the medicine for glycemic control in T2D patients. @Point of Care 1200 Morris Tpke, Suite 3005; Short Hills, NJ 07078; 973.890.8988 The first is Diadems AlzoSure Predict. That drug won FDA approval but then struggled after Medicare limited coverage of the treatment. Introduced in early 2021, H.R.841 would make hemp and its byproducts legal and labeled as a dietary supplement under the FDAs protection and jurisdiction. Aducanumab is an antiamyloid monoclonal antibody, and two more monoclonal antibodies (donanemab and lecanemab) are under review by the US Food and Drug Administration (FDA). Called Aduhelm, the drug controversially won FDA approval last summer despite conflicting results in clinical testing. Securing an obesity-specific FDA approval for the drug would dramatically expand its sales potential. Industry observers had expected Roctavian to win FDA approval in August 2020, but the agency pressed BioMarin to provide at least two years of follow-up data from the Phase 3 trial for the drug. Not giving CBD federal approval made lawmakers write a bill that would force the FDA to do so. Eli Lilly will also seek approval for it to help induce weight loss, among other indications. It is encouraging for other amyloid-lowering therapies, such as gantenerumab and donanemab, that will read out in the coming months. Success with lecanemab would help Biogen recover from its disastrous attempts to sell its first Alzheimers drug. But the lack of data and a lengthy drug approval process at least two years means that we will have to wait and see if lecanemab is the breakthrough drug the world has been waiting for. 5,218 Views. Since then, Aduhelm has earned negligible revenue amid fierce pushback from both doctors and insurers. Biogen lays out awaited Alzheimer's drug data in obscure journal. The company recently secured U.S. FDA approval for its diabetes drug Tirzepatide which is expected to garner over $5 billion in peak sales. The FDA has granted priority review to Acadia Pharmaceuticals application, and is to decide on the application by March 12, 2023. Aducanumab, granted accelerated FDA-approval in June 2021, is a new type of treatment that addresses the disease in a way that has never been done before, compared with other currently approved drugs. A recent study of donanemab from Eli Lilly found 27% of individuals receiving the experimental therapy experienced fluid build up in the brain. This is the first molecule in 20 years that appears to have some effect, however slight, against the progression of this disease. 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