Sanofi

Sanofi and MannKind Announce Afrezza®, the Only Inhaled Insulin, Now Available in the U.S.

Sanofi and MannKind Announce Afrezza^®, 
the Only Inhaled Insulin, Now Available in the U.S.  

Paris and Valencia, Calif. - February 3, 2015 - Sanofi and MannKind Corporation announced today that Afrezza^® (insulin human) Inhalation Powder, the only inhaled insulin, is now available by prescription in U.S. retail pharmacies nationwide. Afrezza is approved by the U.S. Food and Drug Administration to control high blood sugar in adults with type 1 and type 2 diabetes.

"Many people living with diabetes are not able to control their blood sugar on their current medications and may benefit from using insulin. Now they have another option to administer insulin that is not an injection," said Dr. Janet McGill, M.D., Professor of Medicine at Washington University School of Medicine in St. Louis and Afrezza clinical trial investigator. "This delivery option may help change the dialogue between health care professionals and people living with diabetes about initiating or intensifying insulin therapy."

Afrezza is a drug-device combination product that consists of a dry formulation of human insulin delivered from a small and portable inhaler to help patients achieve blood sugar control. Afrezza is rapidly absorbed and has a short duration of action. It is administered at the beginning of a meal.

Afrezza can help control high blood sugar as part of a diabetes management plan that may include diet, exercise and other diabetes medications. Afrezza should not be used in patients with chronic lung disease such as asthma or COPD. Afrezza cannot be used to treat diabetic ketoacidosis. Afrezza is not recommended in patients who smoke or who have recently stopped smoking.

"Afrezza is an important addition to Sanofi's growing diabetes portfolio of integrated, personalized offerings, and it is one that highlights our dedication to bringing innovative therapies to people with this disease," said Pierre Chancel, Senior Vice President Diabetes Division, Sanofi. "There is a recognized need for an insulin that doesn't require an injection, and our organization is committed to making this new treatment option available to patients."

"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," stated Alfred Mann, Executive Chairman, MannKind Corporation.

About Afrezza
Afrezza is a rapid-acting, inhaled insulin used to control high blood sugar in adults with type 1 and type 2 diabetes. The product consists of a dry formulation of human insulin delivered from a small and portable inhaler. Administered at the beginning of a meal, Afrezza dissolves rapidly upon inhalation to the lung and delivers insulin quickly to the bloodstream. Peak insulin levels are achieved within 12-15 minutes of administration. Afrezza is available in 4-unit and 8-unit single-dose cartridges of insulin powder that can be used, as prescribed by a health care professional, in combination with other diabetes medications to achieve target blood sugar levels. For Afrezza doses exceeding 8 units, patients may use a combination of 4 unit and 8 unit cartridges. Other sizes of cartridges are being considered. The disposable inhaler can be used for up to 15 days, should be kept in a clean, dry place with the mouthpiece cover on and may be wiped with a clean, dry cloth if needed.