Early treatment with KINERET reduced disease progression by 64 percent in hospitalized COVID-19 patientsi
The decision is based on results from the SAVE-MORE phase 3 study, which was the first large, pivotal randomized controlled trial to specifically evaluate a COVID-19 patient population at risk of progressing to critical state and demonstrate considerable benefit of earlier intervention for the prevention of disease progression and death. The study, conducted by the
“This is a proud moment for Sobi. The authorization of KINERET comes at a critical time as variants continue to be identified and trigger waves of COVID-19 infection across the
COVID-19 infection may lead to respiratory failure or death due to an overreaction of the infected person’s inflammatory response. KINERET blocks the biologic activity of IL-1 alpha and beta by competitively inhibiting IL-1 binding to the interleukin-1 type I receptor (IL-1RI), which is expressed in a wide variety of tissues and organs. Early treatment before the hyperinflammatory phase can have a significant impact on COVID-19 disease progressioniii.
The emergency use of KINERET for COVID-19-related pneumonia has not been approved or licensed by the FDA, but has been authorized by the FDA under an EUA for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the
Contacts
For the Sobi NA Medical team, please contact medinfo.us@sobi.com. For Sobi media contacts, click here.
About SAVE-MORE
SAVE-MORE (NCT04680949); suPAR-Guided Anakinra Treatment for Management of Severe Respiratory Failure by COVID-19) was a pivotal, confirmatory, Phase III randomized controlled trial. The trial aimed 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
KINERET is an FDA-approved interleukin-1 receptor antagonist used to reduce the signs and symptoms and slow the damage of moderate to severe active rheumatoid arthritis (RA) in people age 18 years and older when one or more other medicines for RA have not worked, to treat people with a form of Cryopyrin-Associated Periodic Syndromes (CAPS) called Neonatal-Onset Multisystem Inflammatory Disease (NOMID) and to treat people with Deficiency of Interleukin-1 Receptor Antagonist (DIRA). KINERET should not be used in patients
The FDA has issued an EUA for the emergency use of KINERET for the treatment of COVID-19 in hospitalized adults with positive results of direct SARS-CoV-2 viral testing with pneumonia requiring supplemental oxygen (low- or high-flow oxygen)
IMPORTANT SAFETY INFORMATION
Before starting KINERET, patients should tell their doctor if they: have any allergies, have kidney problems, are pregnant, plan to become pregnant, are breastfeeding or plan to breastfeed, have any serious illnesses, are scheduled to receive any vaccines (use of KINERET with live vaccines is not recommended).
KINERET and other medicines may affect each other and cause serious side effects. Patients should tell their doctor if they are taking any medicines (prescription, over-the-counter, vitamins, or herbal products), especially, if they take certain medicines that affect the immune system called Tumor Necrosis Factor (TNF) blockers or anti-cytokines.
Patients should not take KINERET if they are allergic to E. coli derived proteins, KINERET, or any components of the product.
KINERET may cause serious side effects, including:
Allergic reactions. Patients should stop using KINERET and call their doctor or get emergency help right away if they experience any of the symptoms of an allergic reaction such as swelling of the face, lips, mouth or tongue, trouble breathing, wheezing, severe itching skin rash, hives, redness, or swelling outside of the injection site area, dizziness or fainting, fast heartbeat or pounding in the chest (tachycardia), and/or sweating.
Low white blood cell count (neutropenia). KINERET may cause patients to have a lower number of certain white blood cells (neutrophils). Patients should have blood tests before starting treatment with KINERET.
The most common side effects of KINERET include:
Increased levels of liver enzymes. KINERET may cause patients to have increased levels of the liver enzymes as determined after a blood test.
Rash.
Injection site skin reactions. The symptoms of injection site skin reactions may include redness, swelling, bruising, itching, and/or stinging.
These are not all the possible risks associated with KINERET.
Please see the KINERET Fact Sheet for Patients and Caregivers at www.KineretRxHCP.com/EUA for additional information.
Report side effects to FDA MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Sobi by calling 1-866-773-5274.
Please see full US prescribing information for KINERET.
About
As the North American affiliate of international biopharmaceutical company Sobi, the
About Sobi
Sobi is a specialized international biopharmaceutical company transforming the lives of people with rare diseases. Providing sustainable access to innovative medicines in the areas of hematology, immunology and specialty care, Sobi has approximately 1,600 employees across
1 https://www.nature.com/articles/d41586-021-03455-w Accessed on
3Kyriazopoulou, E., Poulakou, G., Milionis, H. 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 27, 1752–1760 (2021). https://doi.org/10.1038/s41591-021-01499-z. Accessed on
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