Covid-19 Treatment From Vir, GlaxoSmithKline Is Approved

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 [e-mail]

(END) Dow Jones Newswires

May 26, 2021 18:24 ET (22:24 GMT)

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