GSK

GlaxoSmithKline and U.S. partner Vir Biotechnology will boost production of their antibody-based COVID-19 treatment by adding a second manufacturing plant to help meet soaring demand in the United States.

GSK and Vir Biotechnology said on January 13 they are seeking an expansion to the U.S. approval of their antibody-based COVID-19 treatment to include an option for the therapy to be given as a shot in the arm.

The United States agreed to buy 600,000 more doses of GSK and Vir Biotechnology’s COVID-19 antibody therapy for an undisclosed sum, as the country bolsters its arsenal of treatments against the Omicron coronavirus variant.

GSK said on December 7 the British drugmaker’s antibody-based Covid-19 therapy with U.S. partner Vir Biotechnology is effective against all mutations of the new Omicron coronavirus variant, citing new data from early-stage studies.

According to a Wall Street Journal report, the preferred Covid-19 shot globally is the Pfizer-BioNTech vaccine.

GlaxoSmithKline and Vir Biotechnology said final results from a late-stage study of their monoclonal antibody confirmed sotrovimab significantly reduced hospitalization and death among high-risk Covid-19 patients when given early in the disease.

The U.S. Food and Drug Administration gave an emergency use authorization to the antibody treatment developed by Vir Biotechnology and GlaxoSmithKline for treating mild-to-moderate Covid-19 in people aged 12 years and older.

The European Union’s drug regulator said on May 21 a Covid-19 antibody treatment developed by GlaxoSmithKline and Vir Biotechnology can be used to treat patients who are at risk of severe disease and do not need supplemental oxygen.

Europe’s medicines regulator said on May 7 the EMA has begun a real-time review of the Covid-19 antibody treatment developed by GSK and Vir Biotechnology,, formally kicking off the process for a potential European Union approval.

Antibody treatments from Eli Lilly and Vir Biotechnology reduced viral load in low-risk Covid-19 patients, results from a mid-stage trial showed on March 29.