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The Food and Drug Administration (FDA) has lifted the risk evaluation and mitigation strategy (REMS) requirement for Afrezza (insulin human; MannKind) inhalation powder.
Afrezza was initially approved by the FDA in June 2014 as a treatment for adults with diabetes with a REMS requirement; a REMS modification was later approved on April 20, 2015. The REMS consisted of a communication plan intended to inform prescribers of the potential risks associated with the use of Afrezza as described in the boxed warning (acute bronchospasm in patients with chronic lung disease).
Upon review of the proposed supplemental New Drug Application (sNDA), the FDA has determined that the communication plan is no longer needed as an element of the REMS to ensure the benefits of Afrezza outweigh its risks. The communication plan has been completed and the latest assessment has shown that the plan has met its goals and that no further assessments are needed.
“We are pleased that the FDA determined that a communication plan is no longer necessary to ensure the benefits of Afrezza outweigh its risks and that a REMS is no longer required,” stated Dr. David Kendall, Chief Medical Officer of MannKind.
Afrezza is a rapid-acting inhaled insulin indicated to improve glycemic control in adult patients with diabetes mellitus. It consists of a dry powder formulation of human insulin delivered from a small and portable inhaler. Upon inhalation to the lung, Afrezza dissolves rapidly and passes quickly into the bloodstream (<1 minute).
Afrezza is available as 4 Units, 8 Units, and 12 Units per cartridge in single-dose, color-coded cartridges.
For more information call (800) 633-1610 or visit Afrezza.com.
