Regeneron Pharmaceuticals has paused critically ill COVID-19 patients’ enrollment with its trial studying the antibody cocktail treatment, which was fond of President Trump earlier this month. The choice is because of potential safety concerns.
The drugmaker on Friday said it was suspending the enrollment of hospitalized #COVID-19 patients requiring high-flow oxygen or mechanical ventilation after an unbiased monitoring committee observed “a potential safety signal and an unfavorable risk/benefit profile at the moment.”
The enrollment of individuals in this category should be on hold, pending the collection and evaluation of additional data.
Trials continue to test the antibody cocktail in hospitalized patients necessitating little if any extra oxygen. Other trials involving mild or moderately ill patients also can move ahead.
The drug has revealed encouraging outcomes. Regeneron on Wednesday said early data confirmed the therapy lowered COVID-19 related medical visits by 57 percent.
Regeneron earlier this month asked the foodstuff and Drug Administration for emergency approval and said it could make doses accessible to the American people free of charge. The drugmaker said it might have sufficient doses for 300,000 people when looking at the coming months.
Regeneron stops enrolling critically ill COVID-19 patients …. https://news.immitate.com/2020/10/30/regeneron-stops-enrolling-critically-ill-covid-19-patients-for-antibody-drug-trial-thehill-the-hill/.