The efficacy and safety of ENJAYMO have been studied in two Phase 3 clinical trials.
In one study, participants with CAD with no history of blood transfusion during the 6 months prior to starting the study were randomized to receive either ENJAYMO (N=22) or placebo (N=20). The study was double-blind, meaning that neither the participants nor the researchers knew whether they were receiving ENJAYMO or placebo.
ENJAYMO has also been studied in 24 participants with CAD with at least 1 blood transfusion during the 6 months prior to starting treatment. The study was single-arm and open-label, meaning that all of the participants received ENJAYMO and they knew what drug they were given.
In both studies, responders:
- Improved hemoglobin*
- Remained transfusion free†
- Did not need other medications for CAD
*At least 1.5 g/dL increase in hemoglobin from the start of treatment in the double-blind, randomized, placebo-controlled trial, and a return to at least 12 g/dL or at least a 2 g/dL improvement from the start of treatment in the single-arm, open-label trial
†No blood transfusion from Week 5 through Week 26
The effect of ENJAYMO on other factors was studied, including:
- Hemoglobin levels over time
- Bilirubin levels over time
- Impact of fatigue
- Symptoms of anemia