The Brazilian Health Regulatory Agency (ANVISA) has approved Afrezza inhaled insulin for the treatment of diabetes, and the DPI is expected to be launched in Brazil by the end of 2019, MannKind Corporation said. MannKind announced in May 2017 that it had signed a Brazilian distribution deal for Afrezza with Biomm.
Afrezza was approved by the FDA in 2014 and is currently marketed in the US by MannKind. The company recently announced that AMSL has acquired commercialization rights for Afrezza in Australia. In July 2018, the company announced a deal with Tanner Pharma Group for distribution of Afrezza in additional regions where the DPI was not already approved.
MannKind Corporation CEO Michael Castagna commented, “The regulatory approval of Afrezza in Brazil is an important milestone for MannKind and our partner Biomm. It not only represents our first international approval of Afrezza, but more importantly, we now have the opportunity to bring a novel mealtime insulin therapy to patients in a country with one of the highest prevalence of diabetes in the world, according to the International Diabetes Federation.”
Biomm President Director/CEO Heraldo Marchezini said, “We believe that Afrezza, with its distinct time-action profile and route of administration, will address many of the unmet needs for mealtime insulin therapy and has the potential to change the way that diabetes is treated. As a pioneering biotechnology company, we are proud to leverage our portfolio of diabetes products and offer another option to treat the significant and growing numbers of patients with diabetes in Brazil.”
Read the MannKind and Biomm press release.
