INDIANAPOLIS (Inside INdiana Business) — Eli Lilly and Co. (NYSE: LLY) will be working with the makers of the drug remdesivir to see if a certain drug combination will prove effective against severe cases of COVID-19.
The U.S. Food and Drug Administration 10 days ago authorized emergency use for the antiviral medication, which is produced by California-based Gilead Sciences (Nasdaq: GILD).
A new clinical trial will evaluate the safety and efficacy of a treatment regimen using remdesivir with Lilly’s baricitinib, an FDA-approved treatment for rheumatoid arthritis.
Lilly purchased the licensing rights three years ago for baricitinib from drugmaker Incyte Corp (Nasdaq: INCY). It is marketed under the name Olumiant.
“This is very important to say this is all based on a hypothesis, but we really need to see in a clinic setting will Olumiant bring some value,” said Patrik Jonsson, president of Lilly Bio-Medicines. “By combining those two, we will try to understand would the time to recovery be further accelerated in patients that get the combination versus the group of patients who only get remdesivir.”
Inside INdiana Business first reported last month Lilly was collaborating with the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, to examine if the anti-inflammatory benefits of baricitinib seen in RA patients could have similar efficacy in advanced cases of COVID-19 patients.
Since then, remdesivir received government approval to conduct trials.
“We now have solid data showing that remdesivir diminishes to a modest degree the time to recovery for people hospitalized with COVID-19,” said NIAID Director Dr. Anthony Fauci.
He says this new testing, “will examine if adding an anti-inflammatory agent (baricitinib) to the remdesivir regimen can provide additional benefit for patients, including improving mortality outcomes.”
The federal government released its distribution plans last week. Indiana is one of just 13 states to received shipments of remdesivir in the initial allocation.
The Department of Health and Human Services says Indiana will receive 38 cases of the investigational drug, each containing 40 vials. By comparison, New York state received 560 cases.
HHS says the drug is first being distributed to health departments in some hard-hit states, and the departments can distribute it to hospitals as they see fit.
“We are working with local officials to determine the appropriate patients to treat with this medication,” said Dr. Kristina Box, commissioner of the Indiana State Department of Health. “The federal government initially shipped this to a major hot spot in Indiana.”
The NIH says remdesivir will be administered as an intravenous dose, followed by an oral dose of the Lilly drug. The agency says Oluminant, which is in tablet form, will be crushed or given through a tube into the stomach.
The study is double-blind, meaning neither trial investigators nor participants know who is receiving which treatment regimen.
The California drugmaker says it is scaling up production to rapidly build the supply of the investigational drug. Meanwhile, Lilly’s Jonsson says if regulatory agencies around the world see the value of Olumiant as a treatment for COVID-19, the company is ready to fill the need.
“We don’t see any concerns with our ability to supply Oluniant, first and foremost, to patients currently treated for rheumatoid arthritis. But should we see a clinical effect of Olumiant on COVID-19 patients, we have what it takes to guarantee our supply for those patients,” said Jonsson.
- Indiana State Department of Health coronavirus information (includes phone number to state hotline)
- WISH-TV coronavirus coverage
- Indiana Back on Track plan
- Marion County reopening order from May 13, 2020
- Gr8 Comeback
- Coronavirus COVID-19 global cases map from John Hopkins University
- CDC’s coronavirus page
- Marion County Public Health Department coronavirus information
- Apply for the Economic Injury Disaster Loan program