The U.S. Food and Drug Administration announced Wednesday that it has broadened the approved applications for an arthritis medication manufactured by Organon, allowing doctors to prescribe the drug for dangerous immune system reactions in cancer patients and severe COVID-19 cases requiring respiratory assistance.
Key details of the FDA’s decision include:
• Federal regulators expanded approval for Tofidence, which mimics Roche’s Actemra, to address severe or potentially fatal cytokine release syndrome in certain cancer patients, as well as COVID-19 cases where patients require oxygen therapy or mechanical breathing assistance along with systemic corticosteroids.
• Cytokine release syndrome occurs when the human body produces too many inflammatory proteins.
• Organon announced that Tofidence is now authorized for use in adults and pediatric patients starting at age two for both newly approved medical conditions.
• The medication is classified as a biosimilar, which means it closely replicates Roche’s Actemra that doctors use to treat various forms of arthritis, another condition for which Tofidence already has regulatory approval.
• “In the U.S., biosimilar adoption may help reduce the affordability burden of high-cost brand biologics on the health care system,” said Jon Martin, U.S. commercial lead, biosimilars and established brands, at Organon.
• Organon noted that federal regulators granted Tofidence approval in 2023 as the first American biosimilar alternative to Actemra.
• This past April, India’s Sun Pharmaceutical Industries announced plans to acquire Organon through an all-cash transaction worth approximately $11.75 billion including debt, representing the largest international purchase by an Indian pharmaceutical corporation.
