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 Pfizer’s Exubera was approved in 2006, but was withdrawn in January 2008 because of its high cost and concerns over links to lung cancer.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

28 March 2012 Business

news image

Industry news, April 2012

Most Read

Flushing advice is flawed

24 August 2015 Research

news image

Protocols to restore contaminated water supplies are not based on science

Simple chemistry saving thousands of gold miners from mercury poisoning

25 August 2015 News and Analysis

news image

Basic apparatus is cutting mercury pollution and helping Indonesian miners go for gold

Most Commented

New drug treatment for alcoholism shows promise in animal studies

24 August 2015 Research

news image

Compounds that target a receptor in the brain appear less addictive with fewer negative side-effects than existing drugs

A risky business

28 August 2015 In the Pipeline

news image

Graduate research is likely the most risky time of a chemist’s career, says Derek Lowe