Just as it is for terminally ill cancer patients, time is of the essence for people in the early stages of Alzheimer’s disease. Thus, the clinical meaningfulness of Eli Lilly and Co.’s donanemab is the time it gives patients before the disease progresses, Reisa Sperling, a neurology professor at Harvard Medical School and director of the Center for Alzheimer’s Research and Treatment at Brigham and Women’s Hospital, told the U.S. FDA’s Peripheral and Central Nervous System Drugs Advisory Committee June 10.
For the U.S. FDA’s Peripheral and Central Nervous System Drugs Advisory Committee, the medical need and the effectiveness of Eli Lilly and Co.’s Alzheimer’s candidate, donanemab, outweighs the safety concerns and lack of data for underrepresented groups and special needs patients. The panel voted unanimously, 11-0, June 10 that the available data show donanemab is effective in treating Alzheimer’s in the population enrolled in Lilly’s clinical trials and that the benefits of the amyloid-targeting monoclonal antibody outweigh the risks in the study population of patients with mild cognitive impairment and mild dementia.
An Eli Lilly & Co. patent describes new glucagon-like peptide 1 receptor (GLP-1R) agonists reported to be useful for the treatment of diabetes type 2, hyperglycemia and obesity.
Although the U.S. FDA unexpectedly sprang the news on Eli Lilly and Co. that it would hold an advisory committee meeting on the BLA for the company’s Alzheimer’s disease drug, donanemab, the agency’s briefing document for the June 10 meeting doesn’t appear to hold any surprises.
With its hands full developing QRL-101 and QRL-201, both in clinical trials for amyotrophic lateral sclerosis with plans to expand into other neurodegenerative diseases such as frontotemporal dementia, Quralis Corp. has decided to out-license its preclinical ALS and FTD drug, QRL-204.
Eli Lilly and Co.’s updated phase I/II study of olomorasib as a monotherapy in patients with KRAS G12C-mutant advanced solid tumors yielded more promise in data released over the weekend at the American Society of Clinical Oncology (ASCO) annual meeting.
The American Society of Clinical Oncology (ASCO) meeting opened at the McCormick Place convention center in Chicago with after-lunchtime sessions on breast cancer, melanoma, sarcoma and advancements on adjuvant cancer vaccines. As ASCO revved up, the CEOs of Merck & Co. Inc., Gilead Sciences Inc. and Eli Lilly and Co. vented their frustrations about the impact of the Inflation Reduction Act on innovation.
Aryl hydrocarbon receptor (AhR) agonists have been reported in an Eli Lilly & Co. patent and described as potentially useful for the treatment of psoriasis, atopic dermatitis, ulcerative colitis, multiple sclerosis, Crohn’s disease, rheumatoid arthritis, graft-vs.-host disease and systemic lupus erythematosus.
In lieu of pending guidance, the U.S. FDA’s approval May 20 of Biocon Biologics Ltd.’s Yesafili and Samsung Bioepis Co. Ltd.’s Opuviz as interchangeable biosimilars to Regeneron Pharmaceuticals Inc.’s Eylea (aflibercept) provides further insight into how the agency is approaching the market exclusivity the Biologics Price Competition and Innovation Act awards to the first approved interchangeable for any given biologic.
The radiopharmaceutical revolution rolls on as Eli Lilly and Co. builds on its prowess in the space with a deal that could bring Aktis Oncology Inc. $1.1 billion. The two plan to develop radiopharmaceuticals targeting cancer. Privately held Aktis also is getting $60 million in cash up front along with an equity investment. The big money would come from preclinical, clinical, regulatory, commercial milestones and tiered royalties. Lilly will select the targets.
