U.S. Food and Drug Administration Issues Emergency Use Authorization for KINERET® (anakinra) for the Treatment of COVID-19-Related Pneumonia
Early treatment with KINERET reduced disease progression by 64 percent in hospitalized COVID-19 patientsi
WALTHAM, Mass., Nov. 10, 2022 (GLOBE NEWSWIRE) -- Sobi North America, the North American affiliate of Swedish Orphan Biovitrum AB (Sobi®), today announced that the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for KINERET® (anakinra) for the treatment of Coronavirus Disease 2019 (COVID-19) in adult patients who are hospitalized with positive results of direct SARS-CoV-2 viral testing with pneumonia, requiring supplemental oxygen (low- or high-flow oxygen), and are at risk of progressing to severe respiratory failure, and are likely to have an increased blood level of a certain substance called urokinase plasminogen activator receptor (suPAR) that may be a sign of increased risk of worsening of the disease.
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 Hellenic Institute for the Study of Sepsis, found that early treatment of COVID-19-hospitalized patients with KINERET showed considerable efficacy, and reduced the risk of disease progression by 64 percent. In addition, treatment with KINERET reduced the risk of severe disease or death by 54 percent. Results were published in Nature Medicine on Sept. 3, 2021.
“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 U.S., despite the ongoing vaccinationsii,” said Dr. John Yee, MD, MPH, Chief Medical Officer, Sobi North America. “Today’s decision will provide both patients and treating physicians with an important option against COVID-19 related severe illness and death.”
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 U.S. Food Drug and Cosmetic Act, unless the declaration is terminated or authorization revoked sooner.
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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 World Health Organization clinical progression scale. Anakinra was administered at a dose of 100mg/day SC for up to 10 days. Of 1,060 patients screened, 606 patients were randomized across 40 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.
U.S. INDICATION FOR KINERET® (anakinra)
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 who are allergic to E. coli derived proteins, anakinra, or any components of the product.
U.S. EMERGENCY USE AUTHORIZATION (EUA) FOR KINERET
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) who are at risk of progressing to severe respiratory failure, and are likely to have an increased blood level of a certain substance called urokinase plasminogen activator receptor (suPAR) that may be a sign of increased risk of worsening of the disease . However, KINERET is not approved for this use. KINERET is not authorized for COVID-19 patients younger than 18 years of age.
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.
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 Sobi North America
As the North American affiliate of international biopharmaceutical company Sobi, the Sobi North America team is committed to Sobi’s vision of providing access to innovative treatments that make a significant difference in the lives of individuals with rare diseases. Our product portfolio includes multiple approved treatments focused on immunology, hematology and rare disease. With U.S. headquarters in the Boston area, Canadian headquarters in the Toronto area, and field sales, medical and market access representatives spanning North America, our growing team has a proven track record of commercial excellence. More information is available at www.sobi-northamerica.com or at www.sobi.com.
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 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, sobi-northamerica.com, LinkedIn and Twitter.
1 https://www.nature.com/articles/d41586-021-03455-w Accessed on November 7, 2022.
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 November 7, 2022.