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La FDA publie une lettre de réponse complète au sujet du sutimlimab, un médicament expérimental pour le traitement de l’hémolyse chez l’adulte atteint de la maladie des agglutinines froides

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La FDA publie une lettre de réponse complète au sujet du sutimlimab, un médicament expérimental pour le traitement de l’hémolyse chez l’adulte atteint de la maladie des agglutinines froides*     La lettre de réponse complète se rapporte aux carences issues d’une inspection préalable à l’approbation de la demande de licence menée auprès d’une installation tierce responsable de la fabrication.PARIS – Le 14 novembre 2020 – La Food and Drug Administration des États-Unis a publié une lettre de réponse complète (CRL, Complete Response Letter) au sujet de la demande de licence de produit biologique (BLA, Biologics License Application) relative au sutimlimab, un anticorps monoclonal expérimental pour le traitement de l’hémolyse chez l’adulte atteint de la maladie des agglutinines froides (MAF).  Cette lettre se rapporte à certaines carences effectuées par l’Agence américaine lors d’une inspection (préalable à l’approbation de la demande de licence) menée auprès d’une installation tierce responsable de la fabrication. Aucune lacune clinique ou de sécurité n’a été notée dans la CRL en ce qui concerne la demande. Une résolution satisfaisante des carences par le fabricant tiers est nécessaire pour que la demande de licence soit approuvée ; Sanofi collabore étroitement avec la FDA et ce fabricant pour parvenir à cette résolution dans les meilleurs délais.Pièce jointePress Release

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