© Reuters. FILE PHOTO: The Eli Lilly logo is displayed on one of the company’s offices in San Diego, California, U.S., September 17, 2020. REUTERS / Mike Blake / File Photo
By Leroy Leo
(Reuters) – Eli Lilly (NYSE:) and Co have delayed their application for fast approval of their experimental Alzheimer’s drug, saying they hope such approval will make little difference. with limited Medicare coverage terms.
Shares of Eli Lilly fell 2.6% to $244.21 on Thursday, after the drugmaker said it would complete an application by the end of 2022, pushing back its first quarter, timeline. initial.
The U.S. Centers for Medicaid and Medicare Services has restricted coverage of Alzheimer’s drugs, including the controversial Biogen (NASDAQ:) Aduhelm treatment, to only patients participating in the trials. approved clinical trial.
The agency’s final coverage terms, which will go into effect in April, are expected to apply to all drugs in the class, including Lilly’s donanemab as well as those being developed by Roche Holding AG (OTC:) and Eisai Co (OTC:) Ltd.
Lilly Chief Science Officer Daniel Skovronsky said: “We are trying to get investor focus on the exact timing of expedited approval, given our very limited expectations for impact. of such expedited approval commercially”.
Skovronsky said the company expects data from donanemab’s confirmatory trial in mid-2023, after which it could be clearer on Medicare reimbursements.
“I think people are now expecting that there will probably be no sales for donanemab this year and essentially no sales next year,” said Mizuho Securities analyst Vamil Diwan. .
Lilly said the US Food and Drug Administration will make a decision to use the arthritis drug Olumiant for hospitalized COVID-19 patients by the middle of this year.
The drug is currently authorized in the United States to treat hospitalized COVID-19 patients, and saw sales jump 59% in the fourth quarter.
Lilly beat estimates for fourth-quarter revenue and profit, helped by strong demand for best-selling diabetes drug Trulicity as well as higher sales of COVID-19 antibody therapies.
Fusion Media or anyone associated with Fusion Media shall not bear any liability for loss or damage resulting from reliance on information including data, quotes, charts and buy/sell signals contained in this site. Please be fully informed of the risks and costs associated with trading in financial markets, which are among the riskiest forms of investment possible.