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).
Application details
Product details | |
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Name |
Gamifant
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Active substance |
Emapalumab
|
International non-proprietary name (INN) or common name |
emapalumab
|
Therapeutic area (MeSH) |
Immune System Diseases
|
Anatomical therapeutic chemical (ATC) code |
L04AA39
|
Orphan |
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 | |
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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
News
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 9-12 November 202013/11/2020
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18/09/2020
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24/07/2020