MannKind, BIOMM File Application For Approval Of Afrezza In Brazil

(RTTNews) - MannKind Corp. (MNK) and BIOMM SA announced the submission of a registration dossier to ANVISA, seeking the approval of Afrezza (insulin human) inhalation powder in Brazil. The registration dossier includes recently updated prescribing information for Afrezza, incorporating new clinical data describing the time-action profile of Afrezza.

BIOMM, the first Brazilian biopharmaceutical company, is responsible for registering the product with ANVISA. After approval, the drug will be submitted to CMED (the Brazilian drug price control agency) for release, after which MannKind will supply Afrezza to BIOMM, who will be responsible for the promotion, distribution and sales of Afrezza in Brazil.