FDA Expands Use Of Remdesivir For Some Non-Hospitalized Covid Patients
The Food and Drug Administration authorized Gilead Sciences' antiviral treatment remdesivir to be administered outside of a hospital for some mild-to-moderate covid patients. The intravenous drug that is infused over three days would have to be delivered at an outpatient clinic.
The Washington Post:
FDA Approves Use Of Antiviral Drug Remdesivir As An Outpatient Therapy For People With Covid-19
Federal regulators Friday approved the use of the antiviral drug remdesivir for covid-19 outpatients at high risk of being hospitalized, providing a new treatment option for doctors struggling with shortages of effective drugs to counter the coronavirus. The Food and Drug Administration said the intravenous treatment, which had been limited to patients in the hospital, could be administered to outpatients with mild-to-moderate illness. Remdesivir, manufactured by Gilead Sciences, was among the first coronavirus treatments authorized in 2020. The drug received full agency approval later that year for people 12 and older. Treatment of younger children is permitted under an emergency use authorization, but Friday’s expansion to outpatients includes both age groups. (McGinley, 1/21)
Fox News:
FDA Acts To Expand Use Of Treatment For COVID-19 Patients With Mild-To-Moderate Disease
The agency has expanded the approved indication for Veklury to include its use in adults and pediatric patients 12 years and older – and weighing at least 88 pounds – with positive results of direct SARS-CoV-2 viral testing and who are not hospitalized, have mild-to-moderate COVID-19 and are at high risk for progression to severe disease. The FDA also revised Veklury's emergency use authorization (EUA) to also authorize the drug for treatment of pediatric patients less than 12 years of age, weighing at least 3.5 kilograms to less than 88 pounds, with the same conditions. High-risk, non-hospitalized patients may receive Veklury via intravenous infusion for a period of three days. (Musto, 1/22)
Politico:
Game-Changing Covid Pills Remain Out Of Reach For Some Patients
Antiviral Covid-19 pills were billed as game-changers for the way they could provide a convenient way to treat infections at home and keep people out of the hospital. But that assumed patients could get the drugs quickly. Instead, a flurry of regulatory, testing and logistical issues is complicating the rollout, potentially requiring people with symptoms to make multiple stops at doctors' offices or testing sites within the five-day window when the drugs are recommended. (Gardner, 1/23)
In other news about covid treatments—
Salt Lake Tribune:
Utah Eliminates Race And Sex As Factors In Monoclonal Antibody COVID Treatments After ‘Legal Concerns’
After complaints by right-wing media personalities, Utah is eliminating race and sex as factors in allocating its limited supply of monoclonal antibodies and antiviral treatments for COVID-19. Based on clinical data that showed men and patients of color were at a heightened risk of being hospitalized or dying from COVID-19, state health officials previously had included both markers as risk factors in determining who is eligible for the popular but vanishingly scarce COVID-19 treatments. But the Utah Department of Health on Friday announced that it was now eliminating race and sex in its determinations, citing “legal concerns.” (Alberty, 1/21)
AP:
New Conservative Target: Race As Factor In COVID Treatment
Some conservatives are taking aim at policies that allow doctors to consider race as a risk factor when allocating scarce COVID-19 treatments, saying the protocols discriminate against white people. The wave of infections brought on by the omicron variant and a shortage of treatments have focused attention on the policies. (Richmond, 1/23)
AP:
Newspaper: Maine Monoclonal Doses Drop With Testing Backlog
Maine’s backlog of 46,000 positive COVID-19 tests artificially lowered its numbers of confirmed cases, coinciding with a reduction in the amount of lifesaving monoclonal antibody treatments shipped to the state. Shipments of sotrovimab, one of few medications that are effective against the omicron variant, are rationed by the U.S. Department of Health and Human Services based on hospitalizations and new cases over the previous seven days, the Portland Press Herald reported. (1/23)
In related news —
Stat:
New Effort Aims To Accelerate Clinical Trials For Common Diseases
A group of scientists who did more than perhaps any other to test new treatments for Covid, including establishing that the steroid dexamethasone can save lives, is now turning its focus to the rest of medicine. The first step, announced today: a partnership with the Paris-based drug giant, Sanofi. Sanofi will give the U.K. non-profit Protas $6.8 million to begin its work to accelerate how clinical trials are done and make them far cheaper. It aims to build on what the researchers learned studying treatments against Covid-19 to test medicines for heart disease, cancer, depression, Alzheimer’s, and other common ailments. (Herper, 1/24)
