THE VERGE- SATURDAY, JUNE 28, 2014 2:14 AM GMT
The US Food and Drug Administration today approved a new insulin inhaler for use in treating diabetes, its first in years. The product, which is made by California-based MannKind Corporation, uses a dry powder that people can breath in to control insulin levels. It's been designed not as a full-time replacement to insulin injections, and instead as an alternative to them at meal times given the powder's short-term effects that kick in within what the company says is between 12 to 15 minutes.
Not a replacement for needles or pumps just yet
The drug, which goes by the commercial name Afrezza, is the second such insulin inhaler to get FDA approval, and comes after an earlier version of the device was rejected and sent back for additional testing. Pharmaceutical giant Pfizer tried something similar in 2006 with a drug called Exubera that was pulled off the market just a year later. Exubera was large, required specific measurements of powder packets, and many insurance companies balked at covering it under patient plans. It ultimately cost Pfizer $2.8 billion after sales bombed.
The FDA's approval of Afrezza has some caveats. Its makers must provided warnings on the boxes that patients with asthma and COPD could experience bronchial spasms. MannKind is also being required to do long-term studies on the drug once it's on the market to look out for cardiovascular effects, how the drug affects children, and how it works within the body.
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