STOCKHOLM, Nov. 10, 2022 /PRNewswire/ — Sobi announced today that the U. S. Food and Drug Administration is being able to participate in the U. S. Food and Drug Administration in the U. S. Food and Drug Administration on the Board. The U. S. Food and Drug Administration granted an Emergency Use Authorization (EUA) for the use of Kineret (anakinra) for the remedy of coronavirus disease 2019 (COVID-19) in hospitalized adults with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure.
COVID-19 can progress to severe respiratory failure and death due to an exaggerated inflammatory response1. Kineret is an anti-inflammatory drug that neutralizes the biological activity of the cytokines IL-1a and ß, which play a role in COVID192-induced hyperinflammation. Blocking those cytokines early in the hyperinflammatory phase can have a significant effect on COVID-193 disease progression.
Kineret has been shown to have results, reduce progression to severe respiratory failure and mortality in hospitalized patients with COVID-19 pneumonia requiring supplemental oxygen, and the benefits were maintained over the long term.
“This is another vital milestone for Sobi. La authorization will provide patients and treating physicians in the U. S. with the U. S. to be cleared. “”The U. S. is a treatment option for COVID-19-related pneumonia,” said Anders Ullman, director of research and development and chief medical officer at Sobi.
The approval was based on results from the phase 3 SAVE-MORE study that was published in Nature Medicine on September 3, 2021.
About Emergency Use Authorization Status
Kineret (anakinra) has not yet been approved but is legal for emergency use for the treatment of coronavirus disease 2019 (COVID-19) in hospitalized adults with pneumonia requiring supplemental oxygen (low or low). high oxygen flow) who are at risk of progressing to severe respiratory failure and may have elevated levels of plasma-soluble plasminogen urokinase activator (suPAR) receptors. Emergency use of Kineret is permitted only during the declaration of the lifestyles of cases that warrant authorization for emergency use of drugs and biologics in the COVID-19 pandemic under Section 564(b)(1) of the Act, 21 U. S. C. § 360bbb- 3(b)(1), unless the declaration or authorization revoked above is terminated. See the full fact sheet for health care providers for justifying emergency medication use during the COVID-19 pandemic, information on available opportunities, and more information about COVID-19.
About SAVE-MORE and patient identification
SAVE MORE (NCT04680949); SuPAR-guided Anakinra treatment for the treatment of severe respiratory failure during COVID-19 was a pivotal, confirmatory, phase 3, randomized, double-blind, controlled study. The study evaluated the efficacy and protection of early-onset suPAR-guided Kineret in SARS-CoV-2 patients decreasing respiratory tract infection to the clinical prestige of COVID-19 for 28 days, as measured through the ordinal scale of the World Health Organization Clinical Progression Scale 11. Kineret was administered at a dose of one hundred mg/day SC for up to 10 days. Of 1060 patients evaluated, 606 patients were randomly assigned to 40 sites in Greece and Italy. SAVE-MORE was a researcher-sponsored study conducted independently by Professor Evangelos J. Giamarellos-Bourboulis, the Hellenic Institute for the Study of Sepsis, being the regulatory sponsor. The examination protocol and the full statistical research plan were developed following the recommendation of the EMA’s COVID Emergency Working Group. Sobi supported the study with a study drug and funding.
SuPAR control is not commercially available in the United States. In order to identify a population comparable to that studied in the SAVE-MORE trial, a patient identity choice approach evolved to choose maximum maximum probable patients who had suPAR = 6 ng/mL based on commonly measured patient characteristics. Patients who meet at least 3 of the following 8 criteria at most are likely to have suPAR = 6 ng/mL at baseline.
1. Age = years
2. Severe pneumonia according to WHO criteria4
3. Current/former smoking
4. Sequential Organ Failure (SOFA) score5 = 3
5. Neutrophil-to-lymphocyte ratio (NLR) = 7
6. Haemoglobin = 10. 5 g/dL
7. Ischemic stroke doctor
8. Blood urea = 50 mg/dl and/or history of kidney disease
About Kineret
Kineret (anakinra) is an interleukin-1a and ß receptor antagonist indicated in the United States to reduce symptoms and slow the progression of structural lesions in moderately to severely active rheumatoid arthritis (RA) in patients 18 years of age or older. older adults who have failed one or more disease-modifying antirheumatic drugs (DMARDs); for the treatment of neonatal multisystem inflammatory disease (NOMID), a form of cryopyrin-associated periodic syndromes (CAPS); and for the remedy of interleukin-1 receptor antagonist (ARID) deficiency.
In the EU, Kineret is indicated in adults for the remedy of symptoms and symptoms of rheumatoid arthritis (RA) in admixture with methotrexate, with insufficient response to methotrexate alone. In addition, Kineret is indicated in adults, adolescents, young people and infants from 8 months of age with a body weight of 10 kg or more for the treatment of cryopyrin-associated periodic syndromes (CAPS), adding multisystem inflammatory diseases of neonatal onset (NOMID )/chronic infantile neurological, cutaneous and joint syndrome (CINCA), Muckle-Wells syndrome (MWS), and familial bloodless autoinflammatory syndrome (FCAS). Kineret is indicated for the remedy of Familial Mediterranean Fever (FMF). Kineret deserves to be administered in admixture with colchicine, if appropriate. It is also indicated in adults, adolescents, young people and infants older than 8 months with a body weight of 10 kg or more for the treatment of Still’s disease, adding systemic juvenile idiopathic arthritis (SJIA) and adult Still’s disease (TEA). , with active systemic features of moderate to maximal disease activity, or in patients with continued disease activity after treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) or glucocorticoids. Kineret can be given as monotherapy or in combination with other disease-modifying anti-inflammatory and anti-rheumatic drugs (DMARDs). Kineret is indicated for the treatment of coronavirus disease 2019 (COVID-19) in adult patients with pneumonia requiring supplemental oxygen (low or high flow oxygen) who are at risk of progressing to severe respiratory failure as decided through of the plasma concentration of urokinase. soluble plasminogen receptor activator (suPAR) = 6 ng/ml.
For complete prescribing data in the U. S. For full data on prescribing in the EU, visit https://kineretrxhcp. com/pdf/Full-Prescribe-Information-English. pdf and for complete data on prescribing in the EU, visit the EMA website.
References
1. Tang L, et al. Controlling cytokine typhoon is important in COVID-19. Front Immunol 2020;11:570993. doi: 10. 3389/fimmu. 2020. 570993.
2. Renieris G, et al. IL-1 mediates tissue-specific inflammation and severe respiratory failure in COVID-19. J Innate Immun 2022;1-14. doi: 10. 1159/000524560.
3. Kyriazopoulou E, et al. Early COVID-19 Remedy with Plasma-Guided Anakinra of Soluble Urokinase Plasminogen Receptors: A Phase 3 Randomized, Double-Blind Controlled Trial. Nat Med 2021;27(10):1752-1760. doi: 10. 1038/s41591-021-01499 -z.
4. World Health Organization. (2020, March 13). Clinical control of severe acute respiratory infections (SARIs) in case of suspected COVID-19. Provisional guidance. https://www. who. int/docs/default-source/coronaviruse/clinical-control- de-novela-cov.
5. HHS technical resources, help desk, and information exchange. (2020, December 21). SOFA score: what it is and how to use it in the classification – hhs. gov. https://files. asprtracie. hhs. gov/documents/aspr-tracie-sofa-score-fact-sheet . pdf.
Sobi
Sobi is a global specialty biopharmaceutical company that transforms the lives of others living with rare diseases. Providing sustainable, cutting-edge medicines in the fields of hematology, immunology and specialty care, Sobi has approximately 1600 employees in Europe, North America, the Middle East and Asia. In 2021, revenue amounted to SEK 15. 5 billion. Sobi (STO:SOBI) shares are indexed on the Stockholm Nasdaq. Learn more about Sobi on sobi. com, LinkedIn and YouTube.
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Kineret approved for emergency use through FDA for the treatment of COVID-19-related pneumonia
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