Inhaled insulin is a powdered insulin form, shipped with a nebulizer to the lungs where it is absorbed. In general, inhaled insulin has been absorbed more rapidly than subcutaneously injected insulin, with faster peak concentrations in serum and faster metabolism.
Exubera, developed by Inhale Therapeutics (later Nektar Therapeutics), became the first inhaled insulin product marketed in 2006 by Pfizer, but poor sales caused Pfizer to withdraw it in 2007. Afrezza, an inhaled monomer insulin developed by Mannkind, approved by the FDA in 2014.
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History
Insulin was introduced by Banting and Best of the University of Toronto in 1921 as an injection agent. German researchers first introduced the idea of ​​insulin that could be inhaled in 1924. Years of failure were followed until scientists realized they might be able to use new technology to convert insulin into concentrated powders with particles of inhalation.
In 1980, Nektar Therapeutics developed the technology to make insulin into tiny particles they licensed Pfizer; Alkermes developed a shipping tool they licensed to Eli Lilly and Company.
After concrete methods were developed, human tests began in the late 1990s. In January 2006, the US Food and Drug Administration (FDA) approved the use of Exubera, a form of inhalable insulin developed by Pfizer; it was approved in the UK in August 2006 but replaced by the National Health Service only for people who have trouble with needles; it is not replaced by a US insurance company. A systematic review of 2007 concludes that hexameric inhalation insulin (Exubera) "seems to be just as effective, but no better than short-acting insulin that is injected.An additional cost is so much more so it is impossible to be cost-effective." In 2007, Pfizer announced that it would no longer produce or market Exubera. According to Chairman and CEO Jeffrey Kindler this is because Exubera "failed to gain acceptance among patients and doctors".
At the time of the termination of Exubera, several other companies are pursuing insulin inhalation including Alcermes working with Eli Lilly and Company, MannKind Corporation, and Aradigm working with Novo Nordisk. As of March 2008, all of these products have been discontinued because all investors decide to withdraw their funds, except for Afrezza MannKind products.
On March 16, 2009, MannKind submitted a NDA for insulin that could be inhaled. In 2011 the FDA rejected Afrezza's approval and because the design of the shipping device has changed, the FDA requested additional clinical trials to ensure that people will use it in the same way as previous versions. After further research, Mannkind submitted a new application, and in June 2014, the FDA approved Afrezza for Type I and Type II diabetics, with label restrictions for patients suffering from asthma, active lung cancer or COPD. In 2014, Mannkind and Sanofi agreed that Sanofi would take over the production and marketing of Afrezza, but Sanofi said that the effort was down in January 2016 because of bad sales of $ 7.5 million by 2015; the company officially terminated the agreement in November 2016. By the time Sanofi announced its product fell, Mannkind said it would continue on its own, and had taken over manufacturing and relaunched the drug in July 2016. The company's stocks continued to decline for the last two years as sales increased very slowly and they spend all income on television marketing.
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Footnote
Source of the article : Wikipedia
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