MannKind Corporation has announced that FDA is no longer requiring a Risk Evaluation and Mitigation Strategy (REMS) communication plan for Afrezza inhaled insulin. Afrezza was approved in the US in June 2014, with the FDA requiring a boxed warning about bronchospasm in asthma and COPD patients and several post-marketing studies.
According to the company, the REMS communications plan was modified in April 2015, and two assessments after that time concluded that the plan met its goals.
MannKind Chief Medical Officer David Kendall commented, “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. We are grateful for the FDA’s guidance and expediency in this process, and we look forward to advancing our goal of establishing inhaled insulin as a preferred treatment option for individuals with diabetes who require mealtime glucose control.”
Read the MannKind press release.
