FDA further limits use of GSK’s and Vir’s SARS-CoV-2 antibody sotrovimab

As the omicron BA.2 subvariant has spread, FDA has announced that it will further constrain the use of the investigational monoclonal antibody sotrovimab. The agency announced that it would limit the use of the antibody in some U.S. regions last week. 

GlaxoSmithKline plc (LSE/NYSE:GSK) and Vir Biotechnology (Nasdaq:VIR) were initially confident that the antibody could hold up to the first omicron subvariant, but the companies have concluded that it is probably ineffective against the BA.2 subvariant. 

The FDA has announced that sotrovimab is not currently authorized in areas where the BA.2 subvariant makes up the majority of COVID-19 infections. These areas include the Northeast, much of the Western part of the country and a portion of the Midwest. 

The FDA has also withdrawn authorization for sotrovimab in Alaska and major U.S. territories, including Puerto Rico. 

Last year, FDA similarly limited the use of Lilly’s bamlanivimab (LY-CoV555)…

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FDA amends EUA for SARS-CoV-2 antibody sotrovimab

GlaxoSmithKline plc (LSE/NYSE:GSK) and Vir Biotechnology (Nasdaq:VIR) have announced that FDA has concluded that the investigational monoclonal antibody sotrovimab is unlikely to be effective against the omicron BA.2 subvariant, which will soon dominate the U.S.

FDA has amended the Emergency Use Authorization (EUA) Fact Sheet for sotrovimab and its website to exclude the antibody in certain areas.

GSK and Vir were initially optimistic about the antibody’s ability to target the mutations in the spike protein of the original omicron SARS-CoV-2 variant.

Vir shares dropped 13.56% to $21.81. GSK shares were mostly flat, falling 0.046% to $43.28.

The market for SARS-CoV-2 antibodies has been competitive, but emerging variants have limited use of the therapies.

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recently recommended marketing authorization for AstraZeneca’s (LON:AZN) Evushe…

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Lilly to supply up to 600,000 doses of investigational COVID antibody to U.S. government

Monoclonal antibodies were one of the first weapons to emerge in the battle against COVID-19, but only a single antibody therapy, sotrovimab from Vir Biotechnology and GSK, retains potency against the omicron variant. Two weeks ago, FDA recommended limited use of Eli Lilly’s (NYSE:LLY) bamlanivimab and etesevimab and Regeneron’s (NSDQ:REGN) REGEN-COV (casirivimab and imdevimab), given their diminished protection against omicron.

Eli Lilly, however, said it has found its investigational antibody bebtelovimab retains full neutralizing activity against the variant based on pseudovirus and authentic virus testing.

Lilly also noted that the antibody retains neutralization against the BA.2 subvariant.

Now, the company has reached an agreement with the U.S. government to supply up to 600,000 doses for a price tag of at least $720 million. The supply agreement asks for delivery of that number of doses by March 31. The U.S. has the option of purchasing an additio…

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GSK and Vir aim to ramp up sotrovimab supply during omicron surge

In early December 2021, GlaxoSmithKline (LON:GSK) and its partner Vir Biotechnology (NSDQ:VIR) announced that their COVID-19 antibody therapy sotrovimab appeared to retain efficacy against the omicron variant. 

Now, demand for sotrovimab is eclipsing supplies of the drug as omicron has fueled a record number of infections in the U.S. and elsewhere.  

According to the Wall Street Journal, Glaxo and Vir are moving to get another manufacturing plant on line to ramp up the production of the drug, which is currently produced in a single facility.  

The U.S. has ordered 600,000 doses of the drug for $945.1 million for the first quarter of the year. 

Other countries, including Australia and Canada, are also seeking to procure more of the drug. 

GSK and Vir expect to sell 1.7 million doses internationally through binding agreements. 

This week, WHO revised their COVID-19 therapeutics guidelines, adding sotrovimab to a list of “conditionally …

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GSK and Vir file for EUA for intramuscular administration of sotrovimab to treat COVID-19

GlaxoSmithKline (LSE/NYSE GSK) and Vir Biotechnology (NSDQ:VIR) are seeking to expand the use of the investigational monoclonal antibody sotrovimab.

Intravenous sotrovimab is currently authorized to treat mild-to-moderate COVID-19 in patients at least 12 years of age, weighing at least 40 kg (88 pounds). The authorization is constrained to patients who face a high risk of developing severe COVID-19.

Sotrovimab won emergency use authorization (EUA) in the U.S. in May 2021. In addition, it won EU marketing authorization as an early COVID-19 therapy in December 2021.

The companies note that data from the Phase 3 COMET-TAIL trial found that 500-mg intramuscular injection of the monoclonal antibody was non-inferior to intravenous injection.

Interim data from that trial was published in The New England Journal of Medicine last year. Final data were published as a pre-print on medRxiv. GSK and Vir Biotechnology anticipate that the full data will be publi…

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Sotrovimab wins EU marketing Authorization as an early COVID-19 therapy 

GlaxoSmithKline (LSE/NYSE:GSK) and its partner Vir Biotechnology (NSDQ:VIR) have received marketing authorization from the European Commission for the dual-action monoclonal antibody Xevudy (sotrovimab).

The marketing authorization covers individuals 12 and older who weigh at least 40 kg who do not need supplemental oxygen. It also requires that such individuals have a heightened risk of developing severe COVID-19.

This summer, GSK and VIR had reached a joint procurement agreement with the EC involving 220,000 doses of the drug.

“With today’s marketing authorization we are now able to expand access, and we are discussing with governments how we can bring sotrovimab to more patients,” said Dr. Hal Barron, chief scientific officer and president R&D of GSK, in a statement.

The two companies also have revealed that preclinical data suggest that sotrovimab retains activity against the Omicron variant, which threatens to become the dominant form of …

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GSK and Vir upbeat about efficacy of sotrovimab against Omicron

GlaxoSmithKline (LON:GSK) and its partner Vir Biotechnology (NSDQ:VIR) have announced that their COVID-19 drug sotrovimab continues to offer protection against the mutations in the spike protein of the Omicron SARS-CoV-2 variant.

In March, the two companies received emergency use authorization (EUA) for the drug. The EUA specifically covers the treatment of mild-to-moderate COVID-19 in high-risk adults and children.

Drawing on preclinical research, the two companies suggest that at least one dose of sotrovimab would protect against Omicron, which WHO has categorized as a variant of concern. The preclinical research involved pseudo-virus testing, including 37 mutations in the Omicron variant spike protein.

Formerly known as VIR-7831, sotrovimab is a monoclonal antibody.

The antibody is the first with “preclinical data demonstrating activity against all tested SARS-CoV-2 variants of concern and interest to date, including Omicron, as well as the sti…

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