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Thursday, May 19, 2022

Eli Lilly Asks FDA to Fast Track Drug

 If Indianapolis-based pharma giant Eli Lilly & Co. is granted an emergency use authorization for its leading COVID-19 antibody candidate, Amgen Inc. will have to fulfill its side of a collaboration agreement very soon.Biopharma rivals Amgen in Thousand Oaks and Eli Lilly agreed on a COVID-related collaboration in September — Amgen being responsible for scaling up production of one or more of Lilly’s therapies currently in R&D.The agreement will move into its next stage when world regulatory agencies, including the U.S. Food and Drug Administration, approve at least one of Lilly’s therapies.Lilly is looking to have LYCoV-555 approved for emergency use, the company’s leading antibody treatment resulting from another collaboration with Vancouver-based AbCellera. The virus-neutralizing antibody treatment entered Phase 3 clinical trials to combat the virus at nursing homes. The same treatment is in Phase 2 trials for COVID patients with mild-to-moderate symptoms.Only one week after requesting emergency authorization for LYCoV-555, another government-run trial was paused, testing this same drug in combination with Gilead Sciences antiviral medicine Veklury. Gilead is based in the South Bay area.Lilly did not disclose details as to why the trial was halted, reports said.Other COVID antibody treatments in the pipeline include LYCoV016, which is in Phase 1 trials and the result of yet another collaboration, this time with China’s Junshi Biosciences. The final notable Lilly antibody treatment focuses on treating COVID patients with acute respiratory distress syndrome, currently in Phase 2 clinical trials.“Our teams have worked tirelessly the last seven months to discover and develop these potential antibody treatments,” Dr. Daniel Skovronsky, chief scientific officer for Eli Lilly, said in an Oct. 7 statement. “We believe the data generated to date provide sufficient evidence that both monotherapy and combination therapy may be effective to treat COVID-19 in patients with a high risk for serious outcomes. Lilly is diligently working with regulators around the world to make these treatments available.”Skoronsky said in a September statement that manufacturing capacity is a “crucial next step” once a COVID treatment is approved by a regulatory agency.

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