Meeting documents for the upcoming April 1 meeting of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) on MannKind’s Afrezza inhaled insulin include questions about the efficacy of Afrezza compared to subcutaneous insulin and about data showing that use of the product reduces lung function over time.
Discussion topics for the meeting include:
- “Trials in type 1 diabetes demonstrate that Afrezza provides numerically and statistically less HbA1c reduction than a comparator subcutaneous insulin. Discuss whether the applicant has demonstrated that Afrezza is an effective treatment for patients with type 1 diabetes mellitus.”
- “Trials in type 2 diabetes demonstrate that Afrezza is superior to placebo but is less effective than a short acting subcutaneous insulin comparator. Discuss whether the applicant has demonstrated that Afrezza is an effective treatment for patients with type 2 diabetes mellitus.”
- “Discuss the pulmonary safety findings in the Afrezza clinical development program (acute bronchospasm and pulmonary function decline over time).”
- “Discuss your level of concern with regard to the possible lung cancer risk with Afrezza use.”
The committee will vote whether the data demonstrate sufficient efficacy and safety for approval of Afrezza for both type 1 diabetes and type 2 diabetes.
Read the FDA draft questions document.
Read the FDA briefing document.
