MannKind and BIOMM Submit Registration Dossier to Brazilian Health Regulatory Agency

MannKind (NASDAQ:MNKD) in association with BIOMM announced the submission of a registration dossier to ANVISA, seeking the approval of Afrezza (insulin human) inhalation powder in Brazil.
As quoted in the press release:

The registration dossier includes recently updated prescribing information for Afrezza, incorporating new clinical data describing the rapid time-action profile of Afrezza.

“We are excited to file our first international application for approval of Afrezza in Brazil, which is in the top ten countries with the highest diabetes rates in the world according to the World Health Organization,” said Michael Castagna, Chief Executive Officer of MannKind Corporation. “BIOMM’s expertise in the diabetes market allowed the dossier to be updated quickly with the revised prescribing information, thereby providing physicians and patients, if and when Afrezza is approved in Brazil, with accurate information to achieve better glycemic control at mealtime.”

Click here to read the full press release.

Source: globenewswire.com