Emergency Use Authorization
KINERET for COVID-191
The FDA has issued an Emergency Use Authorization (EUA) for the emergency use of KINERET for the treatment of COVID-19 in hospitalized adults with positive results of direct severe acute respiratory syndrome coronavirus 2 (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 likely to have an elevated plasma soluble urokinase plasminogen activator receptor (suPAR).
The emergency use of KINERET is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization revoked sooner.
Dosing1
The recommended dosage of KINERET for the treatment of adults with COVID-19 is 100 mg administered daily by subcutaneous injection for 10 days. Consider administration of KINERET 100 mg every other day by subcutaneous injection for a total of 5 doses over 10 days in patients who have severe renal insufficiency or end stage renal disease (creatinine clearance <30 mL/min).
The SAVE-MORE study1
The SAVE-MORE study was a randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of KINERET in 594 adult (≥18 years) patients with COVID-19 pneumonia who were at risk of developing severe respiratory failure (SRF). SRF was defined as pO2/FiO2 <150 mm Hg necessitating high-flow oxygenation, noninvasive ventilation (NIV), or mechanical ventilation (MV).
All patients were hospitalized adults with COVID-19 pneumonia, radiologically confirmed by chest x-ray or CT, but which had not progressed to SRF. All enrolled patients in this study were required to have a plasma suPAR level ≥6 ng/mL.
Key exclusion criteria were1:
- pO2/FiO2 <150 mm Hg
- requirement for NIV, MV, or extra-corporeal membrane oxygenation (ECMO)
- <1500 neutrophils/mm3
Primary endpoint1
The primary endpoint of the study was the 11-point WHO Clinical Progression ordinal Scale (CPS), which was compared between the 2 arms of treatment by day 28. The 11-point WHO-CPS provides a measure of illness severity across a range from 0 (not infected), 1-3 (mild disease), 4-5 (hospitalized—moderate disease), 6-9 (hospitalized—severe disease with increasing degrees of NIV, MV, and ECMO), to 10 (dead).
Results1
At the start of treatment, 91% of patients had severe COVID-19 pneumonia and required low- or high-flow supplementary oxygen, and 9% of patients had moderate COVID-19 pneumonia. Eighty-six percent of patients received dexamethasone.
At 28 days, patients treated with KINERET had lower odds of more severe disease according to the WHO-CPS compared to placebo.1,*
*Odds ratio: 0.37 (95% CI 0.26-0.50).
Mortality at 28 days1,†:
†Hazard ratio (HR): 0.48 (95% CI 0.22, 1.04); risk difference: -3.7% (95% CI -7.7%, 0.3%).
SRF at 28 days1,‡:
‡HR: 0.66 (95% CI 0.48, 0.92); risk difference: -11.6% (95% CI -19.4%, -3.8%).
Mortality at 60 days1,2,§,‖:
§HR: 0.56 (95% CI 0.30, 1.04); risk difference: -4.4% (95% CI -9.2%, 0.4%).
‖Data from a post hoc analysis of derived binary endpoints.
The endpoints were not multiplicity controlled.
Safety1
The safety data are based on the evaluation of 405 KINERET-treated patients and 189 placebo-treated patients who were hospitalized with COVID-19 pneumonia in the SAVE-MORE trial. During the study, there were 18 deaths (4.4%) in the KINERET arm and 17 (9.0%) in the placebo arm. Serious infections occurred in 37 patients (9.1%) in the KINERET arm and in 31 patients (16.4%) in the placebo arm.
The overall safety profile in KINERET-treated patients with COVID-19 is similar to that in KINERET-treated patients with rheumatoid arthritis, which is an FDA-approved indication.
Adverse Events Occurring in at Least 1% of Patients in the KINERET Arm and at Least 1% More Frequently Than Observed in the Placebo Arm Through Day 901
aPatients are counted once for each category regardless of the number of events.
SoC, standard of care.
Downloadable Resources for KINERET in COVID-19
KINERET EUA Brochure
DOWNLOADFact Sheet for Healthcare Providers
DOWNLOADFact Sheet for Patients and Caregivers
DOWNLOADFact Sheet for Patients and Caregivers (Spanish/Español)
DOWNLOADFDA Emergency Use Authorization Letter
DOWNLOADNew COVID-19 Technology Add-on Payments (NCTAP)
DOWNLOAD
References: 1. Fact Sheet for Healthcare Providers: Emergency Use Authorization for KINERET. Stockholm, Sweden: Sobi, Inc. 2022. 2. Data on file. Stockholm, Sweden: Sobi, Inc. 2022.