The U.S. FDA has approved the expanded use of Organon's TOFIDENCE, a biosimilar to Roche's Actemra, to treat life-threatening immune reactions. The new indications include Cytokine Release Syndrome (CRS) in cancer patients and hospitalized COVID-19 patients, including pediatric cases, who require breathing support. These approvals, issued between June 10 and June 13, allow the drug to be used for a broader range of critical care and inflammatory conditions.
Organon's biosimilar TOFIDENCE received FDA expansion for treating Cytokine Release Syndrome and hospitalized COVID-19 patients, broadening its critical care application.
Read the full storyThe U.S. FDA approved Organon's biosimilar for treating life-threatening immune reactions in cancer patients and severe COVID-19 cases requiring respiratory support.
The US FDA has expanded the indications for Organon’s biosimilar Tofidence to treat Cytokine Release Syndrome and pediatric COVID-19 cases.