affrezza image

Sanofi’s inhalable insulin goes on sale in US

pharmafile | February 3, 2015 | News story | Sales and Marketing Afrezza, FDA, Mannkind, Sanofi, US, apidra, diabetes, insulin, type 1, type 2 

Sanofi has launched its inhalable insulin Afrezza in the US to control blood sugar in people with type 1 and type 2 diabetes.

Afrezza (insulin human) is a drug device combination delivered via an inhaler. It was approved by the FDA in June, when it became the first ‘ultra-rapid-acting’ mealtime insulin therapy available in the US.

Sanofi acquired the global rights from the manufacturer Mannkind in a $925 million deal that will split the profits between Mannkind and the French pharma giant.

Afrezza is taken at the beginning of each meal, or within 20 minutes of starting to eat. The powder dissolves immediately when inhaled into the lungs and delivers insulin into the bloodstream in around 12 to 15 minutes, compared 45 to 90 minutes for injected rapid acting insulin analogs and 90 to 150 minutes for injected regular human insulin, the company says.

In the US Sanofi competes with Eli Lilly and Novo Nordisk for the injectable insulin market. Pharma companies operating in the diabetes therapy are had sought for decades to produce an inhaled insulin that would be more convenient than insulin injections. But companies have hit many snags in the past.

Pfizer’s Exubera (insulin human [rDNA origin]) inhalation powder was the first such treatment to reach the market, but was later withdrawn in mid-2007 after it failed to catch on with doctors. And Lilly’s AIR insulin product suffered a similar setback in 2008 when it cancelled Phase III trials of its drug due to the “increasing uncertainties in the regulatory environment”.

Mannkind also faced problems when the FDA rejected its first two license applications for Afrezza and demanded more clinical trial data to assess its safety.

Afrezza costs more than twice the price of Apidra (insulin glulisine), Sanofi’s equivalent injectable insulin. But industry analysts Thomson Reuters Cortellis only predict modest sales of Afrezza to generate around $182 million a year by 2019.

This is a tiny fraction of Sanofi’ diabetes’ $7 billion annual sales because of the poor previous experience with Pfizer’s Exubera, and the restrictions on Afrezza’s use in patients with asthma, COPD and people who smoke or who have recently stopped smoking.

“Afrezza is an important addition to Sanofi’s growing diabetes portfolio of integrated, personalised offerings, and it is one that highlights our dedication to bringing innovative therapies to people with this disease,” says Pierre Chancel, senior vice president of Sanofi’s diabetes division.

“There is a recognised need for an insulin that doesn’t require an injection, and our organisation is committed to making this new treatment option available to patients.”

While Alfred Mann, executive chair of MannKind says: “We are extremely proud to see the many years of work that went into developing Afrezza culminate in the day when it is now available to help people manage their diabetes.”

Lilian Anekwe

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