Covid-19 Treatment From Vir, GlaxoSmithKline Is Approved
May 26 2021 - 5:37PM
Dow Jones News
By Joseph Walker
A monoclonal antibody drug to treat early Covid-19 infections
has been authorized by the U.S. Food and Drug Administration, said
Vir Biotechnology Inc. and GlaxoSmithKline PLC, makers of the
drug.
The drug, called sotrovimab, is the third antibody medicine
authorized to treat patients early in the course of disease who are
at high risk of developing severe cases.
Vir and Glaxo said in March that a study of the drug had been
stopped early because it was shown to be highly effective in
reducing hospitalizations or death.
It is unclear what near-term role the drug will play in the
U.S., where new infections are falling and there remains a glut of
unused antibody drugs made by Eli Lilly & Co. and Regeneron
Pharmaceuticals Inc.
So far, the U.S. government has purchased the medicines directly
from the manufacturers and made them available free to patients via
hospitals and health clinics.
Unlike Lilly and Regeneron, Vir and Glaxo don't have contracts
with the U.S. government to buy their drug. Without a pre-purchase
agreement, the companies will have to sell the drug through
existing commercial channels and compete against treatments that
are essentially free of cost.
"The fast pace of Covid-19 vaccinations in the U.S. is
encouraging, yet, despite these aggressive efforts, there is still
a need to help prevent infected patients from developing
complications," said Glaxo Chief Scientific Officer Dr. Hal
Barron.
Vir and Glaxo may have a potential advantage in that their drug
was developed to work against new coronavirus variants that emerge
over time. In April, the FDA revoked authorization for Lilly's
bamlanivimab alone to treat Covid-19 because of the increasing
prevalence of variants that are resistant to the drug.
In most cases, Lilly's drug can still be used in combination
with another Lilly antibody called etesevimab. In May, the
Department of Health and Human Services said it would stop
distributing the combination drug to Illinois because of a rise in
the so-called Brazilian variant in the state.
Regeneron's drug, named REGEN-COV, is a combination of two
antibodies and so far has proven effective against the major
variants that have emerged.
Monoclonal antibodies are modeled on the natural antibodies
produced by the immune system to fight off the new coronavirus. The
drugs require a one-time infusion. In Lilly and Regeneron's
clinical trials, the drugs reduced the risk of hospitalization or
death by 70%.
The drugs haven't had as much uptake as public health officials
had hoped, in part because hospitals have been slow to set up
infusion sites. There has also been a lack of awareness about the
treatments, which drugmakers have sought to combat through
marketing.
As of last week, Lilly and Regeneron had delivered nearly one
million antibody doses to the government, of which 49% have been
used by patients so far, according to HHS.
Write to Joseph Walker at joseph.walker@wsj.com
(END) Dow Jones Newswires
May 26, 2021 18:24 ET (22:24 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
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