Baxter International (NYSE:BAX) shares enjoyed small gains early Monday, after the company disclosed that it has obtained the U.S. Food and Drug Administration emergency use authorization for Regiocit replacement solution used in continuous renal replacement therapy.
The company, out of Deerfield, Ill., announced that under the EUA, Regiocit is authorized to be used as a replacement solution only in adult patients being treated with continuous renal replacement therapy (CRRT) and for whom regional citrate anticoagulation is appropriate during the COVID-19 pandemic.
Acute kidney injury (AKI), a potentially life-threatening condition where the kidneys suddenly stop working and fluid and uremic toxins build up in the body, is one of many complications affecting COVID-19 patients.
A recent meta-analysis of 20 studies evaluated more than 13,000 hospitalized COVID-19 patients, 43% of whom were in the intensive care unit or had severe infection, and found that AKI prevalence was 17%, with a range of 0.5% - 80.3%. CRRT mimics many of the functions of the natural kidney and is the cornerstone of treatment in patients with severe AKI.
A citrate-based replacement solution can be used for regional citrate anticoagulation in patients who are at greater risk of bleeding during CRRT, as it eliminates the need to administer a blood thinner, such as Heparin, to prevent clotting in the circuit. Regiocit is the only authorized citrate-based replacement solution available in the U.S. for use in CRRT during the COVID-19 pandemic.
BAX acquired 39 cents early Monday to $83.89.