Lilly Antibody Treatment Lands FDA Emergency Use Authorization

The U.S. Food and Drug Administration has granted an Emergency Use
Authorization for a COVID-19 antibody therapy developed by
Indianapolis-based Eli Lilly and Co. (NYSE: LLY). The treatment, known as
bamlanivimab or LY-CoV555), is authorized for the treatment of
mild-to-moderate COVID-19 in patients 12 years and older with a positive
COVID-19 test, who are at high risk for progressing to a more severe case of
the disease and/or hospitalization.

Lilly says the EUA is based on a Phase 2 study involving recently-diagnosed,
mild-to-moderate COVID-19 in an outpatient setting.

“This emergency authorization allows us to make bamlanivimab available as a
COVID-19 treatment for recently diagnosed, high-risk patients – adding a
valuable tool for doctors fighting the now-increasing burden of this global
pandemic,” Dave Ricks, chief executive officer of Lilly, said in a news
release. “The rapid development and availability of bamlanivimab could not
have been achieved without the relentless work of our Lilly team,
collaboration across the industry and the urgent work being done by the
government to ensure appropriate allocation to patients who need it the
most.”

Lilly says the treatment should be administered as soon as possible after a
COVID-19 test and within 10 days of the onset of symptoms. Dr. Daniel
Skovronsky, chief scientific officer for Lilly and president of Lilly
Research Laboratories, says when given early, the treatment may help
patients clear the virus and reduce COVID-related hospitalizations.

Lilly says it will begin shipping the treatment immediately to
AmerisourceBergen, which will distribute it as directed by the U.S.
government.

Additionally, Lilly expects to manufacture up to one million doses of
bamlanivimab by the end of the year, for use around the world through early
2021. The U.S. government says it will allocate 300,000 doses of
bamlanivimab to high-risk patients, with no out-of-pocket costs.

Because it is not an official FDA approval, an EUA allows a treatment to be
used on a temporary basis given certain circumstances. Lilly says it does
not replace the formal review and approval process and bamlanivimab remains
an investigational drug.

The treatment continues to be studied in other clinical trials covering a
variety of patient populations impacted by COVID-19. The company says the
results of the trials could be used to support a future Biologics License
Application with the FDA.

One trial involving bamlanivimab was
<www.insideindianabusiness.com/story/42823381/lilly-covid-antibody-t
rial-ends> canceled late last month. The study was sponsored by the National
Institute of Allergy and Infectious Diseases, which said the treatment
showed a “lack of clinical benefit” for patients who have been hospitalized
with COVID-19.

Source: Inside Indiana Business by Gerry Dick