FDA grants expanded access for Direct Biologics' ExoFlo

By The Science Advisory Board staff writers

October 14, 2020 -- The U.S. Food and Drug Administration (FDA) granted expanded access for Direct Biologics' ExoFlo, allowing it to be used to treat patients with COVID-19-associated acute respiratory distress syndrome.

ExoFlo is an investigational new extracellular vesicle drug that is isolated from human bone marrow mesenchymal stem or stromal cells. Expanding access gives doctors the option to administer ExoFlo as a treatment to reverse disease progression in patients.

Though patients are already being enrolled in the company's phase II, placebo-controlled, randomized clinical trial EXIT COVID-19, the expanded access protocol makes ExoFlo available to a broader group of patients with severe COVID-19 who would not meet the "compassionate use" criteria.

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