Sobi and Novimmune have secured approval from the US Food and Drug Administration (FDA) for Gamifant (emapalumab-lzsg), the first and only treatment indicated for Primary Hemophagocytic Lymphohistiocytosis (HLH).

Gamifant is an interferon gamma (IFNγ) blocking antibody to treat paediatric and adult patients with primary HLH, an ultra-rare syndrome of hyperinflammation with high morbidity and mortality.

Sobi president and CEO Guido Oelkers said: “Gamifant will add significant strength to Sobi’s Immunology franchise, along with Kineret and the recent acquisition of the US rights to Synagis.

“Sobi will now focus on ensuring a successful commercialisation of Gamifant for the benefit of HLH patients in the US.”

“We would like to acknowledge the excellent work done by Novimmune to develop and bring this important treatment to approval, and Sobi will now focus on ensuring a successful commercialisation of Gamifant for the benefit of HLH patients in the US.”

The FDA-approved Gamifant based on data obtained from the pivotal Phase II/III study (NCT01818492), which enrolled patients with primary HLH.

Novimmune chief medical officer Cristina de Min said: “Gamifant is the first drug specifically targeted to neutralise IFNγ. Based on the clinical validation of this new target, additional clinical studies are ongoing or being planned with emapalumab in diseases for which IFNγ is considered pathogenic.”

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Reviewed under Priority Review in the US, Gamifant received Orphan Drug Designation, Breakthrough Therapy Designation and Rare Pediatric Disease Designation from the FDA.

Novimmune developed and submitted Gamifant for approval to the FDA.

Through an exclusive licensing agreement announced in July, Sobi acquired the global rights to the antibody from Novimmune.

Primary HLH usually occurs within the first year of life and unless diagnosed and treated, it can rapidly become fatal.