Eraxis Indication Expanded to Include Pediatric Patients

September 25, 2020 – The U.S. FDA has approved an expanded indication for Eraxis® (anidulafungin), manufactured by Pfizer. The drug is now indicated to treat candidemia and other forms of Candida infections (intra-abdominal abscess and peritonitis) in patients who are at least one month of age. Previously, the drug was only approved for adults under this indication.

Candidemia is one of the most common causes of bloodstream infections in hospitalized patients. It occurs when a Candida yeast species enters the bloodstream, leading to illness, long hospital stays, high medical costs, and in some cases death. Candida infections can also affect organs such as the eyes, brain, and kidneys. Risk factors for developing an infection include hospitalization, a weakened immune system, diabetes, abdominal surgery, corticosteroid use, and kidney disease severe enough to require dialysis.

In a clinical study, treatment with Eraxis was successful in over half of pediatric patients ages one month to less than 18 years. Treatment success was defined as a cure (no sign of infection) or improvement in the patient’s condition (significant but incomplete resolution of the infection).

Recommended dosing for pediatric patients is a loading dose of 3mg/kg of body weight on Day 1, administered via intravenous infusion at a rate not to exceed 1.1mg/minute. The total loading dose should not exceed 200mg. Maintenance dosing is 1.5mg/kg once daily at the same infusion rate, with the total dose per day not to exceed 100mg. Treatment should continue for at least 14 days after the last positive culture.

First FDA approved in 2006, Eraxis is also indicated to treat esophageal candidiasis in adults.