COMPANY ANNOUNCEMENT - No. 03-2024 – Inside information -
BIRKERØD,
As previously announced in Company announcement 12-2023,
Today, the FDA has provided input on the additional data that needs to be presented for the FDA to clear suPARnostic® TurbiLatex for commercial use in the US market.
The data comprise additional US data, and
A more detailed plan for obtaining and analyzing the data will be compiled and will depend on biobank sample availability.
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A downloadable PDF version is available on the company’s website.
For further information, please contact:
CEO,
Tel. (+45) 2226 1355, email: jk@virogates.com
Certified Advisor:
Västra Hamnen Corporate Finance
Per Lönn
Tel. (+46) 40 200 250, email: per.lonn@vhcorp.se
About
The company was founded in 2000. Headquartered in
About suPAR and suPARnostic®
suPAR 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. Strong scientific evidence from more than 900 clinical trials and studies show that the higher the level of suPAR, the worse the prognosis for the patient.
The suPARnostic® products can be used to support healthcare professionals in making clinical decisions. The increasing demands on health systems globally and tightening healthcare budgets necessitate efficiency improvements and innovative solutions in hospitals. The use of suPAR in triage in emergency departments can identify patients in low risk of disease progression (supports discharge) and high risk patients that can benefit from early treatment to lower the risk of disease progression. suPARnostic® TurbiLatex is currently available on Roche Diagnostics’ cobas® instruments, Siemens Healthineers ADVIA® XPT and Atellica® instruments, the
About Kineret® (anakinra)
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 https://www.kineretrx.com and for full EU prescribing information please visit the EMA website.
Disclosure regulation
Prospects about the future reflect
Contacts
Jakob Knudsen , CEO, +45 2226 1355, jk@virogates.com
Attachments
- 20240415-Company Announcement 3 - FDA Q-Sub.pdf
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