Direct Biologics LLC, a manufacturer of regenerative medical products, reported on Tuesday the receipt of US FDA expanded access for ExoFlo to treat patients with COVID-19 associated acute respiratory distress syndrome (ARDS) under its national multi-centre, Phase II, placebo controlled, randomized clinical trial (EXIT COVID-19).
Under the expanded access protocol, the company said it will make ExoFlo available to a broader group of patients with severe COVID-19, many of whom would not meet acceptance criteria for EXIT COVID-19, often under conditions of "compassionate use."
ExoFlo is an investigational new drug that has not been approved or licensed by FDA. It is an extracellular vesicle product isolated from human bone marrow mesenchymal stem or stromal cells (MSCs). ExoFlo provides natural bioactive signals that have been shown to modulate inflammation and direct cellular communication, added the company.
This US FDA expanded approval protocol follows multiple approvals for single patient Emergency Investigational New Drug (eIND) applications granted in September and October. The emergency INDs are a mechanism by which physicians can obtain rapid approval to administer medication to a single patient through a direct appeal to the FDA, Direct Biologics concluded.
Chemomab secures new patents for CM-101 monoclonal antibody
argenx receives FDA priority review for VYVGART Hytrulo in CIDP
AffaMed Therapeutics' DEXTENZA NDA accepted by Singapore regulator
AbbVie showcases gastroenterology portfolio at ECCO Congress
Japan approves Sanofi's Dupixent for chronic spontaneous urticaria
Ono partners with Shattuck Labs for bifunctional fusion proteins
Zymedi commences first in human dosage of ZMA001
Bio-Thera Solutions commences dosing in BAT6026 Phase IA/IIB clinical trial
EicOsis Human Health commences EC5026 Phase 1b multiple-ascending dose clinical trial
Takeda's HyQvia approved for maintenance therapy in CIDP patients
Celltrion USA submits CT-P47 Biologics License Application to FDA
Formosa Pharmaceuticals agrees licensing deal in Brazil for APP13007