Lilly Antibody Therapies Given Emergency Authorization

The U.S. Food and Drug Administration has granted an Emergency Use
Authorization for two COVID-19 antibody therapies from Indianapolis-based
Eli Lilly and Co. (NYSE: LLY). The company says the combination of
bamlanivimab and etesevimab can be used for the treatment of
mild-to-moderate COVID-19 in patients 12 years of age and older who are at
high risk for progressing to severe cases or hospitalization.

The EUA is based on the results of a Phase 3 clinical trial
<www.insideindianabusiness.com/story/43234802/lilly-sees-success-wit
h-antibody-treatment-combination> released last month that showed the
combination of the two therapies reduced the risk of hospitalizations and
death from COVID by 70%.

“Bamlanivimab alone under emergency use authorization has already provided
many people with an early treatment option that could prevent
hospitalizations and we are excited to now add an additional therapeutic
option with a similar demonstrated clinical benefit,” said Dr. Daniel
Skovronsky, chief scientific officer for Lilly and president of Lilly
Research Laboratories. “Additionally, with the risk of resistance emerging
as various strains of the virus arise, bamlanivimab and etesevimab together
could potentially allow efficacy against a broader range of naturally
occurring SARS-CoV-2 variants as these new strains spread around the world.”

Lilly says the therapies should be administered together through a single
intravenous infusion as soon as possible after a positive COVID-19 test and
within 10 days of the onset of symptoms.

Additionally, the FDA has authorized shorter infusion times for bamlanivimab
alone, and for the two therapies together. The previously-authorized time
was 60 minutes; now, the infusion time can be as short as 16 minutes for
bamlanivimab or 21 minutes for the combination.

Lilly says it is collaborating with California-based Amgen Inc. (Nasdaq:
AMGN) to manufacture up to 1 million doses of etesevimab for use with
bamlanivimab by mid-2021. The company currently has 100,00 doses ready for
distribution and an additional 150,000 doses are expected to be available
throughout the rest of the first quarter.

“As COVID-19 cases, hospitalizations and subsequent deaths continue to rise,
we are committed to working with the U.S. government to supply our antibody
therapies for use by patients across the country,” said Skovronsky.

In November, Lilly
<www.insideindianabusiness.com/story/42886366/lilly-antibody-treatme
nt-lands-fda-emergency-use-authorization> received an EUA for bamlanivimab
as a single treatment, a move that
<www.insideindianabusiness.com/story/42945023/lilly-antibody-treatme
nt-lands-canadian-authorization> was mirrored by Health Canada a few weeks
later. The company says the authorizations are temporary and the treatments
have not received FDA approval.

Source: Inside Indiana Business with Gerry Dick