MannKind Tops Decade Effort With U.S. Approval of Insulin
This article is for subscribers only.
MannKind Corp. won U.S. approval to sell its inhaled insulin, culminating an almost decade-long effort, with a warning that the product shouldn’t be used by those with asthma or a serious lung disease.
The Food and Drug Administration said yesterday it cleared MannKind’s Afrezza as a fast-acting insulin to be used at meal times for those with Type 1 and Type 2 diabetes. The drug labeling will warn that spasms in the airways of the lung have been seen in patients with asthma and chronic obstructive pulmonary disease and will advise against smokers using the medicine, the agency said in a statement.