£550 million investment into inhaled insulin

Posted on 11 August 2014

A giant drugmaker has agreed to invest up to £550 million (US$925 million) for the rights to an inhaled insulin treatment.

French firm Sanofi confirmed today its deal for Afrezza, the inhalable insulin product which was approved for use by the US Food and Drug Administration (FDA) earlier in the summer.AFREZZA1

Afrezza has not yet been approved for use in the UK or Europe. It is currently in human trials in this country.

But American adults with type 1 or type 2 diabetes can already use it as their mealtime bolus insulin – and Sanofi’s investment represents a vote of confidence in its global potential as an alternative treatment to injections.

The announcement follows research by developers MannKind that found using Afrezza as a mealtime bolus for six months can reduce HbA1c levels in people with type 1, although not by as much as Novo Nordisk’s NovoRapid. The FDA’s approval came with a requirement for MannKind to study the safety of the drug in children, as well as the long-term effects of the drug on lungs.

Afrezza is taken using a thumb-sized inhaler at the start of the meal. It is an ‘ultra-rapid’ insulin, as the peak insulin level in the blood occurs around 12-15 minutes after use, compared to 30-90 minutes for many injected ‘rapid’ insulins.

This speed of action led JDRF to fund a trial using Afrezza in 2010, as part of a programme developing faster insulins for the artificial pancreas. The participants used Afrezza at meals to fine tune their blood glucose levels, alongside the slower-acting insulin being given by the artificial pancreas. This meant that people had smaller blood glucose level peaks at mealtimes.

The field of inhaled insulin is challenging. In 2007, the pharmaceutical company Pfizer withdrew its drug, Exubera, after poor sales and suggestions of an increased risk of lung cancer.

Speaking in June, Chief Executive of JDRF Karen Addington said: ‘The approval of Afrezza means that people living with type 1 diabetes have another option for the way they manage their condition. We will continue to monitor the drug’s progress through the European and UK regulatory and reimbursement systems.’

Commenting on today’s news, she said: ‘It is encouraging to see such a significant investment into inhaled insulin.’