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 Pfizer’s Exubera was approved in 2006, but was withdrawn in January 2008 because of its high cost and concerns over links to lung cancer.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

UC Davis chemist sentenced to four years over explosion

19 November 2014 News and Analysis

news image

Postdoc sentenced over attempt to make explosive device and reckless disposal of hazardous waste

Spanish fly

10 October 2013 Podcast | Compounds

news image

Helen Scales looks at cantharidin, the active ingredient in this famous aphrodisiac

Most Commented

A year of water splitting from one device

21 November 2014 Research

news image

Coating protects electrodes from corrosion to keep photoelectrochemical cell running

Nanostripe controversy in new twist

24 November 2014 Research

news image

Creator of striped nanoparticles insists questions over structures have already been answered and accuses critics of a 'perso...