Shots:
- The US FDA has approved Imaavy (nipocalimab-aahu) for the treatment of wAIHA in pts (≥12yrs.) currently or previously treated with corticosteroids
- Approval was based on the P-II/III (ENERGY) trial, which assessed 2 different dose schedules of Imaavy vs PBO in 115 adults living with wAIHA for 24wks. followed by an OLE period, where pts received Imaavy for 144wks. with a follow-up of 6wks. after last assessment
- In the trial, Imaavy achieved durable Hgb responses in nearly three times more pts than PBO by Wk. 24, with a mean 1g/dL Hgb increase by Wk. 1 & a 3.5-point higher mean FACIT-Fatigue score vs PBO at Wk. 24
Ref: PRnewswire | Image: J&J | Press Release
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