Gamifant

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emapalumab

Refused
This medicine was refused authorisation for use in the European Union.

Overview

After re-examining its initial opinion, the European Medicines Agency has confirmed its recommendation to refuse marketing authorisation for the medicine Gamifant. The medicine was intended for the treatment of primary haemophagocytic lymphohistiocytosis (HLH) in children under 18 years of age.

The Agency issued its opinion after re-examination on 12 November 2020, following its initial opinion on 23 July 2020. The company that applied for authorisation of Gamifant is Swedish Orphan Biovitrum AB (publ).

This EPAR was last updated on 23/03/2021

Application details

Product details
Name
Gamifant
Active substance
Emapalumab
International non-proprietary name (INN) or common name
emapalumab
Therapeutic area (MeSH)
Immune System Diseases
Anatomical therapeutic chemical (ATC) code
L04AA39
OrphanOrphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Application details
Marketing-authorisation applicant
Swedish Orphan Biovitrum AB (publ)
Date of opinion
17/09/2020
Date of refusal of marketing authorisation
07/01/2021

Assessment history

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