Sobi’s Gamifant (emapalumab) Receives FDA Approval for Primary Haemophagocytic Lymphohistiocytosis (HLH)

 Sobi’s Gamifant (emapalumab) Receives FDA Approval for Primary Haemophagocytic Lymphohistiocytosis (HLH)

Sobi’s Gamifant (emapalumab) Receives FDA Approval for Primary Haemophagocytic Lymphohistiocytosis (HLH)

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

Click here to read full press release/ article | Ref: Sobi | Image: WSJ

Vartika Singh

Vartika Singh is a content writer who loves to write research articles and reports at PharmaShots. She has in-depth knowledge of the life sciences industry including the Pharma and Biotech sectors. Any articles written by her can be contacted at connect@pharmashots.com.

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