Hellenic Institute for the Study of Sepsis

STOCKHOLM, Nov. 10, 2022 /PRNewswire/ -- Sobi® today announced that the US Food and Drug Administration has granted Emergency Use Authorisation (EUA) for the use of Kineret® (anakinra) for the treatment of coronavirus disease 2019 (COVID-19) in hospitalised 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 excessive inflammatory response1. Kineret is an anti-inflammatory medicine that neutralises the biological activity of both cytokines IL-1α and β, which play a role in COVID19-induced hyperinflammation2. Blocking these cytokines early in the course of the hyperinflammatory phase can have an important impact on COVID-19 disease progression3. Kineret was shown to improve outcomes, reduce progression to severe respiratory failure and mortality in patients hospitalised with COVID-19 pneumonia requiring supplemental oxygen, and the benefits were maintained long-term. "This is another important milestone for Sobi. The authorisation will provide both patients and treating physicians in the US with a treatment option against COVID-19 related pneumonia," said Anders Ullman, Head of Research & Development and Chief Medical Officer at Sobi. The authorisation was based on results from the SAVE-MORE phase 3 study which were published in Nature Medicine on 3 September 2021. About Emergency Use Authorisation status Kineret (anakinra) has not been approved but has been authorised for emergency use for the treatment of coronavirus disease 2019 (COVID-19) in hospitalised adults with positive results of direct SARS-CoV-2 viral testing with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure and likely to have an elevated plasma soluble urokinase plasminogen activator receptor (suPAR). The emergency use of Kineret is only authorised for the duration of the declaration that circumstances exist justifying the authorisation of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb- 3(b)(1), unless the declaration is terminated or authorisation revoked sooner. See full fact sheet for healthcare providers for the justification for emergency use of drugs during the COVID-19 pandemic, information on available alternatives, and additional information on COVID-19. About SAVE-MORE and patient population identification SAVE-MORE (NCT04680949); suPAR-Guided Anakinra Treatment for Management of Severe Respiratory Failure by COVID-19 was a pivotal, confirmatory, phase 3 double-blind randomised controlled study. The study evaluated the efficacy and safety of early start of Kineret guided by suPAR in patients with lower respiratory tract infection by SARS-CoV-2 in improving the clinical state of COVID-19 over 28 days, as measured by the ordinal scale of the 11-point World Health Organization clinical progression scale. Kineret was administered at a dose of 100mg/day SC for up to 10 days. Of 1,060 patients screened, 606 patients were randomised across 40 sites in Greece and Italy. SAVE-MORE was an investigator-sponsored study conducted independently by Professor Evangelos J. Giamarellos-Bourboulis, with the Hellenic Institute for the Study of Sepsis being the regulatory sponsor. The study protocol and the full statistical analysis plan was developed after advice from the COVID-Emergency Task Force of the EMA. Sobi has supported the study with study drug and funding. The suPAR assay is not commercially available in the US. In order to identify a comparable population as was studied in the SAVE-MORE trial, an alternative patient identification method was developed to select patients most likely to have suPAR ≥ 6 ng/mL based on commonly measured patient characteristics. Patients meeting at least three of the following eight criteria are considered likely to have suPAR ≥ 6 ng/mL at baseline. 1. Age ≥ 75 years 2. Severe pneumonia by WHO criteria4 3. Current/previous smoking status 4. Sequential Organ Failure Assessment (SOFA)5 score ≥ 3 5. Neutrophil-to-lymphocyte ratio (NLR) ≥ 7 6. Haemoglobin ≤ 10.5 g/dL 7. Medical history of ischemic stroke 8. Blood urea ≥ 50 mg/dL and/or medical history of renal disease About Kineret® Kineret (anakinra) is an interleukin-1α and β receptor antagonist that is indicated in the US for reduction in signs and symptoms and slowing the progression of structural damage in moderately to severely active rheumatoid arthritis (RA), in patients 18 years of age or older who have failed one or more disease modifying antirheumatic drugs (DMARDs); for the treatment of neonatal-onset multisystem inflammatory disease (NOMID), a form of cryopyrin-associated periodic syndromes (CAPS); and for the treatment of Deficiency of Interleukin-1 Receptor Antagonist (DIRA). In the EU, Kineret is indicated in adults for the treatment of the signs and symptoms of rheumatoid arthritis (RA) in combination with methotrexate, with an inadequate response to methotrexate alone. In addition, Kineret is indicated in adults, adolescents, children and infants aged 8 months and older with a body weight of 10 kg or above for the treatment of cryopyrin-associated periodic syndromes (CAPS), including neonatal-onset multisystem inflammatory disease (NOMID)/chronic infantile neurological, cutaneous, and articular syndrome (CINCA), Muckle-Wells syndrome (MWS) and familial cold auto inflammatory syndrome (FCAS). Kineret is indicated for the treatment of Familial Mediterranean fever (FMF). Kineret should be given in combination with colchicine, if appropriate. It is also indicated in adults, adolescents, children and infants aged 8 months and older with a body weight of 10 kg or above for the treatment of Still's disease, including Systemic Juvenile Idiopathic Arthritis (SJIA) and Adult-Onset Still's Disease (AOSD), with active systemic features of moderate to high disease activity, or in patients with continued disease activity after treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or glucocorticoids. Kineret can be given as monotherapy or in combination with other anti-inflammatory drugs and disease-modifying antirheumatic 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 determined by plasma concentration of soluble urokinase plasminogen activator receptor (suPAR) ≥ 6 ng/ml. For full US prescribing information please visit and for full EU prescribing information please visit the EMA website. References 1. Tang L, et al. Controlling Cytokine Storm Is Vital 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 treatment of COVID-19 with anakinra guided by soluble urokinase plasminogen receptor plasma levels: a double-blind, randomized controlled phase 3 trial. Nat Med 2021;27(10):1752-1760. doi: 10.1038/s41591-021-01499-z. 4. World Health Organization. (2020, March 13). Clinical management of severe acute respiratory infection (SARI) when covid-19 disease is suspected. Interim Guidance. . 5. HHS Technical Resources, Assistance Center and Information Exchange. (2020, December 21). SOFA score: What it is and how to use it in triage - hhs.gov. . Sobi® Sobi is a specialised international biopharmaceutical company transforming the lives of people with rare diseases. Providing sustainable access to innovative medicines in the areas of haematology, immunology and specialty care, Sobi has approximately 1,600 employees across Europe, North America, the Middle East and Asia. In 2021, revenue amounted to SEK 15.5 billion. Sobi's share (STO:SOBI) is listed on Nasdaq Stockholm. More about Sobi at sobi.com, LinkedIn and YouTube. Contacts To contact the Sobi Investor Relations Team, please click here. For Sobi Media contacts, click here. The following files are available for download: SOURCE Swedish Orphan Biovitrum AB

WALTHAM, Mass., Sept. 07, 2021 (GLOBE NEWSWIRE) -- Swedish Orphan Biovitrum AB (publ) (Sobi™) (STO:SOBI) and the Hellenic Institute for the Study of Sepsis today announce that Nature Medicine has published positive results from the investigator-sponsored Phase 3 SAVE-MORE randomized controlled trial evaluating anakinra plus standard of care (SOC) versus placebo plus SOC in hospitalized adult patients with COVID-19 pneumonia as measured by the 11-point World Health Organization Clinical Progression Scale at day 28. The study demonstrated that patients treated with anakinra were significantly more improved than those treated with placebo (P<0.0001). Additional analyses showed that early and targeted use of anakinra, in addition to current SOC, reduces risk of death, reduces ICU admission and increases likelihood of full recovery in hospitalized COVID-19 patients with poor prognosis due to risk of severe respiratory failure. The SAVE-MORE study, conducted by the Hellenic Institute for the Study of Sepsis, is among the first large, pivotal randomized controlled trials to specifically evaluate a patient population at risk of progressing to critical state and demonstrate considerable benefit of earlier intervention for the prevention of disease progression and death. Co-administered treatments were similar between the two arms of the study and included dexamethasone, anticoagulants and remdesivir. The study results were previously reported in May. “The results published in Nature Medicine provide the only data available on prevention from early stage progressing to critical status, indicating that the inflammatory disease needs to be treated earlier with a specifically targeted approach to IL-1α alpha and IL-1β,” said lead investigator Evangelos J. Giamarellos-Bourboulis, Professor of Internal Medicine and Infectious Diseases, National and Kapodistrian University of Athens, President of the European Shock Society and Chairman of the European Sepsis Alliance. "Publication of the SAVE-MORE study results in Nature Medicine demonstrates the significance of these data and further advances our understanding of the role of IL-1 in COVID-19,” said Guido Oelkers, CEO of Sobi. “We hope to contribute to an improvement of care for patients during this critical time and welcome the opportunity to work closely with the European Medicines Agency (EMA) and other regulatory agencies regarding these results." About SAVE-MORE SAVE-MORE (NCT04680949); suPAR-Guided Anakinra Treatment for Management of Severe Respiratory Failure by COVID-19) is a large, pivotal, confirmatory, phase III randomized controlled trial (RCT) in over 600 hospitalised patients. The trial aims to evaluate the efficacy and safety of early start of anakinra guided by suPAR in patients with LRTI by SARS-CoV-2 in improving the clinical state of COVID-19 over 28 days, as measured by the ordinal scale of the 11-point World Health Organization (WHO) clinical progression scale (CPS). Anakinra was administered at a dose of 100mg/day SC for up to 10 days. Of 1,060 patients screened, 606 patients were randomised 2:1 across 37 sites in Greece and Italy. SAVE-MORE is an investigator-sponsored study conducted independently by Professor Giamarellos-Bourboulis, with the Hellenic Institute for the Study of Sepsis being the regulatory sponsor. Sobi has supported the study with study drug and funding. About Kineret® (anakinra) Kineret® is an interleukin-1 α and β receptor antagonist that is indicated in the US for reduction in signs and symptoms and slowing the progression of structural damage in moderately to severely active rheumatoid arthritis, in patients 18 years of age or older who have failed one or more disease modifying antirheumatic drugs (DMARDs), for the treatment of neonatal-onset multisystem inflammatory disease (NOMID, a form of cryopyrin-associated periodic syndromes (CAPS)), and for the treatment of Deficiency of Interleukin-1 Receptor Antagonist (DIRA). In Europe, Kineret is indicated in adults for the treatment of the signs and symptoms of rheumatoid arthritis (RA) in combination with methotrexate, with an inadequate response to methotrexate alone. In addition, Kineret is indicated in adults, adolescents, children and infants aged 8 months and older with a body weight of 10 kg or above for the treatment of cryopyrin-associated periodic syndromes (CAPS), including - neonatal-onset multisystem inflammatory disease (NOMID)/chronic infantile neurological, cutaneous, and articular syndrome (CINCA), Muckle-Wells syndrome (MWS) and familial cold auto inflammatory syndrome (FCAS). Kineret is indicated for the treatment of Familial Mediterranean fever (FMF). Kineret should be given in combination with colchicine, if appropriate. It is also indicated in adults, adolescents, children and infants aged 8 months and older with a body weight of 10 kg or above for the treatment of Still’s disease, including Systemic Juvenile Idiopathic Arthritis (SJIA) and Adult-Onset Still’s Disease (AOSD), with active systemic features of moderate to high disease activity, or in patients with continued disease activity after treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or glucocorticoids. Kineret can be given as monotherapy or in combination with other anti-inflammatory drugs and disease-modifying antirheumatic drugs (DMARDs). For full US prescribing information visit and for full European prescribing information visit the EMA website. Anakinra has not been approved for the treatment of COVID -19. About suPAR and suPARnostic® suPAR (soluble urokinase plasminogen activator receptor) is the biomarker detected by ViroGates’ suPARnostic® products and is a protein in plasma, measurable in every human being. suPAR is considered a general risk status biomarker indicating disease presence, disease severity and progression, organ damage and mortality risk across disease areas such as cardiovascular diseases, kidney diseases, type 2 diabetes, cancer, etc. suPAR is approved by EMA for use in Europe but is not currently approved by FDA for use in the United States. About the Hellenic Institute for the Study of Sepsis The Hellenic Institute for the Study of Sepsis (HISS) is a non-profit organisation situated in Athens. HISS coordinates the research activities in sepsis and severe inflammatory disorders since 2010 of 58 departments of Internal Medicine and Intensive Care Units in Greece and abroad. HISS has sponsored the conduct of more than 30 clinical studies and has a track record of providing support for more than 100 publications. The phase II SAVE trial and the phase III SAVE-MORE trial were regulatory sponsored by HISS. For more details visit . Contact details: Evangelos J. Giamarellos-Bourboulis egiamarel@med.uoa.gr; Leda Efstratiou insepsis@otenet.gr About Sobi Sobi is a specialised international biopharmaceutical company transforming the lives of people with rare diseases. Sobi is providing sustainable access to innovative therapies in the areas of haematology, immunology and specialty indications. Today, Sobi employs approximately 1,500 people across Europe, North America, Middle East, and Asia. In 2020, Sobi's revenue amounted to SEK 15.3 billion. Sobi's share (STO:SOBI) is listed on Nasdaq Stockholm. You can find more information about Sobi at For more information, please contact Paula Treutiger, Global Head of Communication +46 733 666 599 paula.treutiger@sobi.com David Caruba, Director of Communications +1 908-347-0154 david.caruba@sobi.com Maria Kruse, Corporate Communication & Investor Relations +46 767 248 830 maria.kruse@sobi.com