FDA authorises another antibody treatment for high-risk COVID patients

The Food and Drug Administration on Wednesday authorised a monoclonal antibody drug developed by GlaxoSmithKline and Vir as the third treatment of its kind cleared to help keep high-risk COVID patients out of the hospital.

>>Rebecca RobbinsThe New York Times
Published : 27 May 2021, 02:40 PM
Updated : 27 May 2021, 02:40 PM

In laboratory tests, the newly authorised drug, known as sotrovimab, has been able to neutralise the virus variants first identified in Britain, South Africa, Brazil, California, New York and India. The federal government, which has so far purchased the other antibody treatments given to COVID patients in the United States, has not announced any plans to purchase the new drug.

GSK has been in conversations with the US government and is “working through existing commercial channels to make sotrovimab available to patients and health systems in need,” said Kathleen Quinn, a company spokesperson.

The company said in a news release that it expects the drug to become available in the US “in the coming weeks.”

The new treatment may offer an advantage as concerns rise about new virus variants that may evade some antibody drugs.

The federal government has paused shipments of one antibody treatment on the market, a regimen of two drugs from Eli Lilly, to eight states because of the high prevalence there of the variants first seen in South Africa and Brazil. Lab experiments suggest those variants can resist Lilly’s treatment. (The other available antibody treatment, a two-drug combo from Regeneron, appears to neutralize the array of variants, based on lab tests.)

GSK and Vir’s treatment is a single drug, designed to mimic the antibodies generated naturally when the immune system fights off the coronavirus, like those detectable after someone infected with it recovers. Its authorization was based on a study of 583 volunteers who had started experiencing symptoms within the previous five days. The study found that those who got the GSK-Vir treatment showed an 85 percent reduction in their risk of hospitalisation or death, compared with those who got a placebo.

Even as vaccination numbers rise and infection rates fall in the United States, antibody treatments are likely to remain an important tool for preventing bad outcomes in high-risk patients, doctors say. Thousands of people in the United States are still testing positive, and hundreds are dying, each day.

Last week, the FDA broadened the criteria that doctors can use to determine eligibility for the treatment, opening the door for more young people with certain medical conditions like hypertension, and members of racial or ethnic groups considered to be at higher risk than others for bad medical outcomes.

“Ultimately, it gives prescribers a lot of latitude in what they can give this for,” said Dr Walid Gellad, who directs the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh.

But the drugs from Lilly and Regeneron have not been used as widely as expected for a range of reasons, according to public health experts.

The antibody drugs are cumbersome to administer. Patients often don’t know to ask for them or where to find them. And many doctors were skeptical of the evidence supporting the treatments when they first became available last November, although that has changed as more clinical trials have reported impressive results.

“There’s still a role for these,” Gellad said. “The problem is just people aren’t getting them who could benefit from them, and having another one on the market doesn’t necessarily solve that.”

GSK and Vir’s treatment, like the other antibody drugs, must be administered via intravenous infusion by a health care provider, which will make it harder to access. The drugmakers are testing a formulation injected intramuscularly, like a vaccine, but it is not expected to be available soon.

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