ØU kommentar: Senest 67 dage efter EMA godkendelsen af svenske Sobis Anakinra, ventes EU kommissionen at give endelig formel markedsføringstilladelse til at sælge produktet. 67 dage fra EMA’s godkendelse er sidste halvdel af februar 2022, hvorefter salget altså kan starte. Med den fortsatte udbredelse smitteudbredelse og mange sygehusindlæggelser ser vi et betydeligt potentiale for både Sobi og Virogates. Bemærk, at vi har Virogates i ØU’s Portefølje.
COMPANY ANNOUNCEMENT – No. 24-2021 – Inside information – 16 December 2021
BIRKERØD, DENMARK – ViroGates A/S, a medical technology company developing blood tests for better triaging in hospitals to improve patient care and reduce healthcare costs, today 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 suPAR-guided 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]. Based on previous trial results, suPARnostic® was chosen as the tool to identify patients at risk of progressing to severe respiratory failure to guide anakinra treatment. Anakinra is an anti-inflammatory therapy that targets the cytokines IL-1α/β, which play a role in COVID-19-induced hyperinflammation. Blocking IL-1α/β before the hyperinflammatory phase can have an important impact on COVID-19 disease progression[ii].
The positive opinion is based on results from the SAVE-MORE phase 3 trial 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 a poor prognosis, identified by suPARnostic®.
Jakob Knudsen, CEO of Virogates, says: ”We are pleased with the positive opinion from the CHMP for suPAR-guided anakinra treatment of COVID-19 patients. The strong phase 3 trial results show that treating patients with high suPAR levels is an important tool for healthcare professionals in battling the global pandemic.”
Jesper Eugen-Olsen, CSO of ViroGates, says: “Once again, we would like to congratulate and sincerely thank Professor Giamarellos-Bourboulis and his team for this important work conducted under challenging conditions. We will continue to support subsequent dialogues with the EMA and initiate dialogues with other regional and national health authorities to ensure suPAR is widely available to patients with COVID-19 pneumonia and clinicians.”
