Shots:

• The approval is based on P-II/III (NCT01818492) study results assessing Gamifant IV in patients with primary HLH- evaluating its safety- efficacy and tolerability
• The P-II/III study resulted in meeting 1EPs with meaningful and significant overall response and 70% achieved HSCT 
• Gamifant (emapalumab) IV is a mAb with its directed usage of over one hour twice per week- binds to neutralizes interferon gamma (IFNy) and has also received ODD & PRIME designation from EMA

Ref: Sobi | Image: WSJ