WALTHAM, Mass., Nov. 10, 2022 (GLOBE NEWSWIRE) -- Sobi North America, the North American affiliate of Swedish Orphan Biovitrum AB (Sobi®), today announced that the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for KINERET® (anakinra) for the treatment of Coronavirus Disease 2019 (COVID-19) in adult patients who are hospitalized with positive results of direct SARS-CoV-2 viral testing with pneumonia, requiring supplemental oxygen (low- or high-flow oxygen), and are at risk of progressing to severe respiratory failure, and are likely to have an increased blood level of a certain substance called urokinase plasminogen activator receptor (suPAR) that may be a sign of increased risk of worsening of the disease.
The FDA has added another drug to its evolving roster of COVID-19 medicines. The agency authorized (PDF) Sobi's Kineret for patients hospitalized with the virus and who are on pneumonia, require supplemental oxygen, are at risk for progressing to severe respiratory failure and are likely to have an elevated level of a specific protein.
EMA has started evaluating an application to extend the use of Kineret (anakinra) to include treatment of coronavirus disease 2019 (COVID-19) in adult patients with pneumonia who are at risk of developing severe respiratory failure (inability of the lungs to work properly).
The National Institute for Health and Care Excellence (NICE) has recommended Sobi’s Kineret for the first-line treatment of the rare inflammatory disorder Still’s disease.
The UK’s National Institute for Health and Care Excellence (NICE) has issued a positive recommendation for Kineret (anakinra) to be used as a first-line biologic therapeutic option for Still’s disease.
STOCKHOLM, Feb. 16, 2021 /PRNewswire/ -- Swedish Orphan Biovitrum AB (publ) (Sobi™) announces that the Ministry of Health of the Russian Federation has approved Kineret (anakinra) for the treatment of Cryopyrin associated periodic syndromes (CAPS).
WALTHAM, Mass., Dec. 22, 2020 (GLOBE NEWSWIRE) -- Sobi™, an international biopharmaceutical company dedicated to rare diseases, announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for KINERET® (anakinra) for the treatment of deficiency of IL-1 receptor antagonist (DIRA).
WALTHAM, Mass., Dec. 22, 2020 (GLOBE NEWSWIRE) -- Sobi™, an international biopharmaceutical company dedicated to rare diseases, announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for KINERET® (anakinra) for the treatment of deficiency of IL-1 receptor antagonist (DIRA).
Biovitrum's Kineret (Anakinra) Receives Supplemental Approval in US
Sobi UK and Ireland has announced the launch of Kineret across the country offering a new treatment option for Adult Onset Stills Disease (AOSD) and Systemic-Onset Juvenile Idiopathic Arthritis (SJIA).