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Sanofi and MannKind Partner to Bring Ultra-Rapid Inhaled Insulin Afrezza to Market by Early 2015

Twitter summary: New Sanofi & MannKind partnership to bring inhaled insulin Afrezza to US in early 2015, presumably primarily to type 2 patients to start

On August 11, Sanofi and MannKind announced a partnership to bring MannKind’s FDA-approved ultra-rapid inhaled insulin Afrezza to market. The companies plan to launch Afrezza in the US by March 2015 for type 1 and type 2 patients. Sanofi should be a strong partner and we think they will be successful bringing Afrezza to many people assuming it is priced the same as other rapid acting insulins and that reimbursement is made a major priority by Sanofi. Sanofi has a major global presence (it sells insulin in 120 countries), deep experience marketing the world’s bestselling insulin Lantus (insulin glargine), and significant regulatory, drug development, and reimbursement expertise.

Afrezza is an ultra-rapid-acting inhaled insulin that the FDA approved on June 27, 2014 after a patient-driven Advisory Committee meeting. Afrezza peaks in just 12-15 minutes, making it much faster than current rapid-acting insulins (Humalog, Novolog, and Apidra) that generally take about 45-90 minutes to peak. In phase 3 trials, type 1 patients taking Afrezza experienced equivalent glycemic control to Novolog, with less hypoglycemia and less weight gain. In type 2s, Afrezza added to pills led to a significant 0.4% improvement in A1c compared to those who took pills alone; in addition, twice as many patients on Afrezza reached an A1c <7%.

Since a puff of Afrezza is equivalent to either four or eight units of an injected rapid- acting insulin, we believe it will be best suited for patients with type 2 diabetes; however, Afrezza could be helpful as an ultra-fast correction dose in type 1 patients, or for very large meals. Afrezza’s inhaled delivery may especially appeal to patients who are afraid of needles, especially the significant percentage of type 2 patients who delay starting on insulin. We also believe it may well be easier for doctors and nurses to prescribe since word on the street is that it is less associated with hypoglcyemia, although that is not actually on the label.

The palm-sized inhaler device should reduce the stigma of visible injections, something both type 1 and type 2 patients report experiencing. Afrezza does have minor respiratory side effects – in its phase 3 trials, 20-30% of those on Afrezza experienced a cough, compared to none of the participants on Novolog. Patients should not use Afrezza if they have chronic lung problems, such as asthma or COPD.  Before initiation of Afrezza, an evaluation of lung function (e.g., spirometry) should be performed.

Questions still remain on pricing and reimbursement, but assuming Afrezza is priced similarly to other rapid-acting insulins, we don’t envision it will be an issue for type 2 patients to get this reimbursed since it would be used in place of other rapid acting insulins that would presumably otherwise be paid for. For type 1 patients, it’s another story since this will be requested as an another product for patients, and one that would be used as a complement, not a substitute. We can definitely envision it improving management – this is going to be really interesting to see what happens and of course we’ll keep you updated! We do think if it works well for type 1 in correction doses, that advocates will lobby hard to get it and get it paid for. At diaTribe, we look very forward to getting our hands on some to test drive.   –NL/AB/KC

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