FDA approves new insulin inhaler for diabetics

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.

7 Replies

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  • Wait for 5 years before using it. Expensive lesson learned by diabetics who went on AVANDIA from GSK. Many died of heart attacks before it was finally banned recently. Many whistle blowers had been saying that GSK has manipulated trials data, but whistle-blowers aren't welcome in medical and academic world.

    GSK finally settled with 3 billion dollars as fines after pleading guilty for frauds that included AVANDIA:

    nytimes.com/2012/07/03/busi...

    Unlawful behavior in drug companies is not an exception but part of their business model.

  • Yes ,we have to wait for Maybe 2,3 years before it's efficacy is proved

    Even for asthma ,,the inhalers took 5 years before doctors started recommending it

    Now it is the easiest and best medicine,,it is a wonder drug for asmatics,,,personally I have not visited hospital for the past 30 years since I started using inhalers ,

    my father had to be taken to hospital for drips and injections everyday at nights during winter,,for his asthma ,,now I don't remember the last time he had gone to hospital ,may it is 25 years

    Because he was reluctant to use inhalers for a long time ,he was against me for using inhalers ,,

    Today we can say it's the greatest gift from God for asthmatics,

    Hope the same type of gift comes to diabetes

  • It is only cut and paste.Copy right infringement according to one member.

  • it was on my facebook, i tried to forward thru FB but could not do it. So i pasted on this forum, so that everybody should know the progress our medical teams to fight diabetics

    Thanks

  • Right in the first sentence he has provided ATTRIBUTION with source, date time.THE VERGE is a site of VOX Media. So this is NOT Violation.

    "THE VERGE- SATURDAY, JUNE 28, 2014 2:14 AM GMT "

    When you quote verbatim with attribution to source it is not violating copyright. On most finance sites, entire data is copied from yahoo finance but attribution is provided. It wouldn't harm to equip yourself with some basic knowledge before trying to make such comments. Else it is nothing but just "Blabbering".

    No response to you after this. In fact you don't even deserve a reply after this on this thread.

  • Thanks for enlightining.

  • How soon the product will be available?

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