Newest Monoclonal Antibody Therapy Permitted for Excessive-Threat Sufferers

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

In laboratory tests, the newly approved drug sotrovimab was able to neutralize the virus variants identified for the first time in Great Britain, South Africa, Brazil, California, New York and India. The federal government, which has so far bought the other antibody treatments for Covid patients in the US, has not announced any plans to purchase the new drug.

GSK has held discussions 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 spokeswoman.

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

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

The federal government has stopped delivering an antibody treatment that is on the market, a cocktail made from two drugs by Eli Lilly, to eight states, as the variants, which are occurring for the first time in South Africa and Brazil, are widespread there. Laboratory experiments suggest that these variants can withstand Lilly’s treatment. (The other antibody treatment available, a cocktail of two drugs from Regeneron, appears to be neutralize the number of variants based on laboratory tests.)

Treatment for GSK and Vir is a single drug that mimics the antibodies naturally produced when the immune system fights off the coronavirus, as demonstrated after a person infected with it has recovered. The approval was based on a study of 583 volunteers who had experienced symptoms in the previous five days. The study found that those who received GSK-Vir treatment had an 85 percent lower risk of hospitalization or death than those who received a placebo.

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

Last week the FDA expanded the criteria doctors use to determine eligibility for treatment, and opened the door to more young people with certain medical conditions, such as high blood pressure, and people from races or ethnic groups who are at greater risk of poor medical outcomes than others.

“Ultimately, it gives the prescribers a lot of leeway to give this for,” said Dr. Walid F. Gellad, who directs the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh.

According to public health experts, Lilly and Regeneron’s drugs have not been used as frequently as expected for a variety of reasons.

The antibody drugs are all cumbersome to administer. Patients often do not know whether to ask for them or where to find them. And many doctors were skeptical of the evidence backing the treatments when they first became available last November. However, that has changed as more clinical studies have reported impressive results.

“There’s still a role for this,” said Dr. Gellad. “The only problem is, people don’t get them that could benefit from them, and having another one in the market doesn’t necessarily solve that.”

Treatment for GSK and Vir, like the other antibody drugs, must be administered via an intravenous infusion from a healthcare provider, making it difficult to access. Drug manufacturers are testing a formulation that will be injected intramuscularly like a vaccine, but it is not expected to be available anytime soon.

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