FDA Determines that Afrezza REMS Communication Plan Has Met Goals and REMS No Longer Necessary

- April 26th, 2018

MannKind (Nasdaq:MNKD), focused on the development and commercialization of inhaled therapeutic products for patients with diseases such as diabetes and pulmonary arterial hypertension, today announced that the Food and Drug Administration (FDA) has completed its review of a supplemental New Drug Application (sNDA) for Afrezza (insulin human) inhalation powder and has determined that the Risk … Continued

MannKind (Nasdaq:MNKD), focused on the development and commercialization of inhaled therapeutic products for patients with diseases such as diabetes and pulmonary arterial hypertension, today announced that the Food and Drug Administration (FDA) has completed its review of a supplemental New Drug Application (sNDA) for Afrezza (insulin human) inhalation powder and has determined that the Risk Evaluation and Mitigation Strategy (REMS) communication plan regarding the risks of Afrezza has been completed and has met its goals. As a result, the FDA has decided that a REMS is no longer required for Afrezza.

As quoted in the press release:

“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. “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.”

The FDA approved the original REMS for Afrezza in June 2014, and a REMS modification took effect in April 2015. The REMS consisted of a communication plan intended to inform prescribers of Afrezza of the potential risks associated with the use of Afrezza as described in the boxed warning. Two subsequent REMS assessments were conducted following Afrezza’s approval, and both assessments found that the communication plan met its goals.

Click here to read the full press release.

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