SILVER SPRING
Tofidence indication expanded to pediatric COVID-19 and CRS
- Sponsor
- Organon $OGN
- Drug
- Tofidence · tocilizumab-bavi
- Indication
- cytokine release syndrome and pediatric COVID-19
FDA approved Tofidence for cytokine release syndrome and pediatric COVID-19 based on Organon's supplemental biologics license application.
What this means
Tofidence is a biosimilar version of tocilizumab, an antibody drug that blocks a protein called IL-6 to calm overactive immune responses. Today FDA approved Tofidence for treating cytokine release syndrome and COVID-19 in children, expanding its previous adult-only label. This decision gives pediatric patients access to a lower-cost alternative to the original drug, potentially easing treatment for severe immune reactions.
Drug Watch — recent news on Tofidence
- Tocilizumab Access and Patient Education Shape Outpatient Bispecific Therapy - Pharmacy Times
- Biosimilar Makers Push Forward on Regulatory and Commercial Fronts - Center for Biosimilars
- Real-World Data Support Tocilizumab for Systemic Sclerosis - EMJ
- Organon wins FDA nod to expand TOFIDENCE use in severe CRS & COVID-19 - MSN
- Is TOFIDENCE’s Expanded CRS and COVID Label Altering The Investment Case For Organon (OGN)? - Yahoo Finance
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