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    SOBI   SE0000872095

SWEDISH ORPHAN BIOVITRUM AB (PUBL)

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Kineret® Receives Positive Opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency for Treatment of Patients with Covid-19 Pneumonia

12/16/2021 | 09:00am EDT

Swedish Orphan Biovitrum AB (publ) (Sobi(TM)) announces that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion of Kineret® (anakinra) 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) = 6ng/ml. EMA has recommended approval for use of Kineret in COVID-19 to the European Commission which will issue a final decision. COVID-19 infection can lead to death due to an overreaction of the infected person's inflammatory response, often referred to as a 'cytokine storm'[i]. Anakinra is an anti-inflammatory therapy that targets the cytokines IL-1-/ß, which play a role in COVID-19-induced hyperinflammation. Blocking IL-1-/ß before the hyperinflammatory phase can have an important impact on COVID-19 disease progression The positive opinion is based on results from the SAVE-MORE phase 3 study which found that early identification of candidate patients with suPAR followed by treatment with anakinra resulted in a 64% relative reduction of patients progressing into severe disease and death, in a 55% relative decrease in mortality, which reached 80% relative decrease in mortality for patients with cytokine storm. Results were published in Nature Medicine on 3 September 2021. The SAVE-MORE study used learning from previous trials and demonstrated the effectiveness of anakinra therapy in patients who had not yet progressed to severe respiratory failure but had poor prognosis, identified by a plasma biomarker of inflammation. Kineret® is an interleukin-1 - and ß 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).


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Sales 2022 17 553 M 1 762 M 1 762 M
Net income 2022 2 377 M 239 M 239 M
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