FDA issues EUA for sotrovimab, third monoclonal antibody to treat COVID-19
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The FDA has issued an emergency use authorization for the monoclonal antibody sotrovimab to treat mild-to-moderate COVID-19 in patients at risk for progressing to severe disease, according to a press release.
The emergency use authorization — now the third for a monoclonal antibody in the treatment of COVID-19 — is specifically for adults and children aged 12 years and older who weigh at least 40 kg, or approximately 88 pounds. It is not intended for patients who are hospitalized or require oxygen due to COVID-19.
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“With the authorization of this monoclonal antibody treatment, we are providing another option to help keep high-risk patients with COVID-19 out of the hospital,” Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a press release. “It is important to expand the arsenal of monoclonal antibody therapies that are expected to retain activity against the circulating variants of COVID-19 in the United States.”
According to the release, sotrovimab (VIR-7831, GlaxoSmithKline) is specifically directed against the spike protein of SARS-CoV-2 and is designed to block the virus’ attachment and entry into human cells. The emergency use authorization is based on an interim analysis from a randomized, double-blind, placebo-controlled phase 1/2/3 clinical trial, which included 583 non-hospitalized adults with mild-to-moderate COVID-19 symptoms and a positive SARS-CoV-2 test. Among these patients, 291 received sotrovimab while the remaining 292 were assigned the placebo. Treatment began within 5 days of symptom onset.
The primary endpoint was COVID-19 progression — defined as hospitalization for more than 24 hours for acute management of any illness or any-cause death — through day 29.
According to the FDA, hospitalization or death occurred in 7% of patients in the placebo group, compared with 1% of those who received sotrovimab, representing an 85% reduction.
Sotrovimab has not demonstrated any benefit in patients who are hospitalized due to COVID-19. Monoclonal antibodies may be associated with worse clinical outcomes when administered to hospitalized patients requiring high flow oxygen or mechanical ventilation, the press release said.
In their own press release, GlaxoSmithKline officials hailed the decision, but also noted a need to prevent complications in infected individuals.
“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,” Hal Barron, MD, chief scientific officer and president of research and development at GlaxoSmithKline, said in the company release. “In just over a year since starting our collaboration and in less than 10 months since beginning clinical trials, we are delighted that, as of today, the benefits of this unique monoclonal antibody will now be available to patients in need.”
The emergency use authorization allows the drug to be administered as a 500 mg, intravenous single dose. The authorization requires that fact sheets be made available to health care providers and patients, parents and caregivers featuring information on the potential side effects, which include anaphylaxis and infusion-related reactions, rash and diarrhea.
Perspective
Back to TopCassandra Calabrese, DO, and Leonard Calabrese, DO
This is the third EUA issued for a monoclonal antibody therapy for COVID-19 and we believe this is important for rheumatologists. These therapies are indicated for outpatient use in patients with mild-to-moderate COVID-19 in both adults and pediatric patients (aged >12 years) who have conditions that carry risk of disease progression.
Among our patients, this would include patients with inflammatory diseases, especially those on therapies associated with risk of severe disease including glucocorticoids, rituximab, antimetabolites, as well as patients with active disease, patients with end organ damage or patients attended by other comorbidities known to contribute to risk (such as cardiovascular disease and obesity).
More importantly, we urge all rheumatologists to network with COVID-19 care teams at their local hospitals to know how to refer for these therapies as it is a critical element to get the treatment started early. Recently, we conducted a Twitter poll in which over half of respondents (i.e., self-identified rheumatologists) were either unaware or lacked confidence that they could engage this care type of care pathway.
Finally, rheumatologists should pay attention to the field as it is changing rapidly as these monoclonals are highly susceptible to viral variants, which lead to escape, and the FDA is closely monitoring.
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