The European Medicines Agency’s (EMA) Committee for Human Medical Products (CHMP) issued a positive scientific opinion on sotrovimab, a Covid-19 treatment candidate developed by GSK and Vir Biotechnology, GSK said.
The CHMP’s evaluation involved the use of sotrovimab for adults and adolescents (aged 12 and older and weighing at least 40 kg) with Covid-19 who do not need oxygen treatment but are at risk of progressing to severe Covid-19.
The regulatory authorities in EU member countries can consider the CHMP’s opinion when deciding to authorize the use of the investigational treatment before giving marketing approval.
The CHMP’s decision was based on the interim results of the phase-3 COMET-ICE trial, which tested sotrovimab’s monotherapy effect for the early treatment of Covid-19 in adults at high risk of hospitalization, according to GSK.
The interim trial data from 583 randomized patients showed that sotrovimab reduced the risk of hospitalization or death by 85 percent compared to placebo, GSK said.
GSK added that the Independent Data Monitoring Committee (IDMC) recommended that the trial be discontinued for enrolment due to evidence of the drug’s effectiveness.
The CHMP also considered sotrovimab’s quality and safety data during the review, GSK said. The CHMP also assessed data from several in vitro studies where sotrovimab’s activity was maintained against multiple variants of the Covid-19 virus, including those from Brazil, California, South Africa, and the U.K.
BioRxiv recently published additional in vitro data showing activity against New York and India variants, but the clinical impact of the variants is unknown yet, GSK said.
The company went on to say that as sotrovimab binds to a conserved epitope of the spike protein, it is less likely to mutate over time, adding that it was still collecting and analyzing data.
GSK applied for Emergency Use Authorization (EUA) of the U.S. FDA, and the Canadian health authorities are reviewing sotrovimab through the “expedited interim order.”
Sotrovimab is an experimental treatment and has not obtained the regulatory nod anywhere in the world.
Christopher Corsico, senior vice president of GSK’s Development, said, “As the COVID-19 pandemic continues and the virus generates new variants of concern, including those that recently emerged in India, the need for therapies that can slow the progression of disease in patients who are at high risk for developing severe complications remains a top priority.”
As less than 40 percent of adults in the EU have received at least one dose of a vaccine, monoclonal antibody treatments are critical to combating Covid-19, he said.
It was encouraging to receive a positive scientific opinion from the EMA, Corsico went on to say. He added that the positive view could help the company provide sotrovimab for Covid-19 patients across Europe.
George Scangos, CEO of Vir Biotechnology, said the company’s most recent in vitro data showed sotrovimab was potent against evolving Covid-19 and all circulating variants of concern.
“We look forward to continuing to work with regulators around the world to make sotrovimab available to more patients in need and help bring an end to the pandemic,” Scangos said.