Johnson & Johnson (NYSE:JNJ) on Thursday presented detailed results from its Phase 2/3 ENERGY study showing that IMAAVY (nipocalimab-aahu) achieved a statistically significant, durable hemoglobin response in patients with warm autoimmune hemolytic anemia (wAIHA).
The rare blood disorder occurs when the immune system mistakenly produces IgG antibodies that attack and destroy healthy red blood cells at normal body temperatures.
Read Also: Positive China Trial Data Moves HUTCHMED Closer To Rare Blood Disorder Drug Filing In 2026 JNJ Drug Demonstrates Durable Hemoglobin Response The company said patients receiving the 30 mg/kg dose experienced a rapid onset of effect and were about three times more likely to achieve durable hemoglobin improvements than those receiving a placebo over 24 weeks.
The randomized, placebo-controlled trial evaluated IMAAVY against placebo using a stringent primary endpoint focused on durable hemoglobin improvement.
To meet the endpoint, patients had to achieve a hemoglobin increase of at least 2 g/dL from baseline, maintain hemoglobin levels of at least 10 g/dL, meet the criteria across at least three visits beginning by Week 16, and avoid rescue therapy or changes to background medications.
