Lilly Teams with Gilead for Potential COVID-19 Treatment
Indianapolis-based 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 drug maker 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
<www.insideindianabusiness.com/story/42000876/lilly-to-study-use-of-
arthritis-drug-to-treat-covid19> 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 Olumiant, 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 drug maker 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 Olumiant, 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.
Source: Inside Indiana Business with Gerry Dick