REMS Requirement Removed for MannKind’s Afrezza

FDA has approved a MannKind supplemental NDA for Afrezza (insulin human) inhalation powder to remove a required Risk Evaluation and Mitigation Strategy (REMS) communication plan. The drug was approved in 2014 and included the REMS related to a Boxed Warning advising that acute bronchospasm had been observed in patients with asthma and chronic obstructive pulmonary disease. “Two subsequent REMS assessments were conducted following Afrezza's approval, and both assessments found that the communication plan met its goals,” the company says. “The release of the REMS means that no further assessments are necessary; had it not been released, additional assessments would have been conducted at seven years post-approval. The Afrezza website, www.afrezzarems.com, will be inactivated, and the company will no longer be required to distribute the Afrezza fact sheet at scientific meetings.”