Inhaled insulin approved in US


The US Food and Drug administration (FDA) has approved an insulin inhaler for managing diabetes mellitus. Mannkind’s Afrezza is aimed at reducing the need for patients to inject themselves with insulin so frequently. In Europe, the Committee for Medicinal Products for Human Use has recommended that a ‘biosimilar’ long-acting insulin be approved, although this product is the subject of a patent infringement lawsuit in the US.

Inhalable insulin has been a target for pharma companies for several years. Pfizer’s Exubera was approved in 2006, but was withdrawn in January 2008 because of its high cost and concerns over links to lung cancer. Mannkind has taken three attempts to get Afrezza approved by the FDA, after being sent back to complete further clinical trials. While the FDA has approved Afrezza, the decision comes with significant limitations. It still requires patients to inject a long-acting insulin as well as the inhaler, and cannot be used by patients with chronic lung diseases like asthma.

Eli Lilly and Boehringer-Ingelhiem’s long acting Abasria insulin injection has the same amino acid sequence as Sanofi’s Lantus (insulin glargine), which means that it is classed as a biosimilar for regulatory purposes in Europe. Abasria is the first insulin product to pass through Europe’s biosimilars regulatory pathway. Because of differing definitions, it is not classed as a biosimilar in the US, which led Sanofi to file a patent infringement lawsuit against Lilly in January. 


Related Content

Sanofi snaps up inhaled insulin licence

12 August 2014 Business

news image

Deal gives Mannkind access to global manufacturing and distribution for recently-approved Afrezza

Business roundup

26 September 2008 Business

news image

Industry news

Most Read

Breakup reaction hints at handedness of nature

25 September 2014 Research

news image

Dissociation of 3-bromocamphor provides clues on why nature favours one mirror image of a molecule over another

Perovskite solar cells show hydrogen production promise

26 September 2014 Research

news image

Highly efficient solar cells and catalysts made from cheap, common materials use sunlight to split water

Most Commented

Viruses melt ‘glassy’ DNA

1 October 2014 Research

news image

Researchers have shown how viruses liquefy their own DNA ready to inject into host cells

Perovskite solar cells show hydrogen production promise

26 September 2014 Research

news image

Highly efficient solar cells and catalysts made from cheap, common materials use sunlight to split water