April 24, 2018
FDA
We have determined that the communication plan is no longer necessary as an element of the REMS to ensure the benefits of Afrezza (insulin human) inhalation powder outweigh its risks because the communication plan has been completed and the most recent assessment demonstrated that the communication plan has met its goals. No further assessments are necessary to assess the current communication plan.
Therefore, because the communication plan is no longer necessary to ensure the benefits of the drug outweigh the risks, a REMS is no longer required for Afrezza (insulin human) inhalation powder.
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022472Orig1s017ltr.pdf
risk evaluation and mitigation strategy (REMS)
The REMS for Afrezza (insulin human) inhalation powder was originally approved on June 27, 2014.
The goal of the Afrezza REMS is to mitigate the risk of acute bronchospasm associated with Afrezza by:
- Informing healthcare providers that there is risk of acute bronchospasm associated with AFREZZA in patients with chronic lung disease.
- Informing healthcare providers that acute bronchospasm has been observed with AFREZZA in patients with asthma and COPD.
- Informing healthcare providers that AFREZZA is contraindicated in patients with chronic lung disease.
- Informing healthcare providers of the need to evaluate patients for lung disease before starting on AFREZZA.