FDA Updates Afrezza® Prescribing Information
Now Includes New Data Regarding Rapid Onset of Activity and Duration of Effect
WESTLAKE VILLAGE, Calif., Oct. 02, 2017 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq:MNKD) (TASE:MNKD) today announced that the U.S. Food & Drug Administration (FDA) has approved an update to the Afrezza prescribing information to include new clinical data that was presented at the American Diabetes Association's 76th Scientific Sessions in June 2016. Afrezza (insulin human) inhalation powder is approved by the FDA to improve glycemic control in adult patients with type 1 and type 2 diabetes mellitus. It is the only inhaled rapid-acting mealtime insulin available in the United States. Afrezza is dosed at the beginning of a meal and begins to appear in the blood in approximately one minute¹.
Key highlights of the label update:
"These data articulate the rapid-acting nature of Afrezza to address post-prandial hyperglycemia, setting it apart from other mealtime options available to help patients maintain greater control over their blood glucose levels," said Satish Garg, MD, MBBS, DM — Barbara Davis Center for Diabetes (BDC) — University of Colorado.
Details of the label update:
1) Clinical Pharmacology (Section 12): The basis of this label change comes from a randomized, controlled, six-treatment, crossover dose-response study comparing Afrezza to the rapid-acting insulin analog, lispro, in 30 patients with type 1 diabetes. The data highlighted below demonstrates the importance of understanding the time to peak effect and time for effect to return to baseline.
2) Dosage and Administration (Section 2): The Dosing Information section has been updated with "Step 1" to inform how patients on injected mealtime insulin should initially be dosed on Afrezza (Figure 1). Additionally, "Step 2" was added to highlight that mealtime dose adjustments may be required based on the individual metabolic needs and glycemic control goals.
Figure 1. Mealtime AFREZZA Starting Dose Conversion Table
3) Use in Specific Populations (Section 8): The Pregnancy and Lactation sections of the label have been updated to conform to the current FDA label guidance. These areas have been configured to provide healthcare providers with clearer risk benefit information for informed decision making in these populations.
In conjunction with the approved labeling revision, MannKind received a letter of Fulfillment of Post-Marketing Requirements for PMR 2166-2 and PMR 2166-3, satisfying two of the four post-marketing requirements for Afrezza as described in the 2014 FDA approval letter.
"Available data suggests approximately 70% of people living with diabetes on insulin are not at HbA1c goals of <7% ²," said Michael Castagna, Chief Executive Officer, MannKind Corporation. "We firmly believe that in order for patients to achieve better HbA1c goals, control of mealtime glucose spikes is critical. This label update supports Afrezza as a unique fast-acting mealtime insulin that provides doctors and patients with the flexibility necessary to help them achieve glycemic control."
About MannKind Corporation
ABOUT DIABETES MELLITUS
LIMITATIONS OF USE
Afrezza is not recommended for the treatment of diabetic ketoacidosis.
Afrezza is not recommended in patients who smoke or who have recently stopped smoking.
IMPORTANT SAFETY INFORMATION FOR AFREZZA
WARNING: RISK OF ACUTE BRONCHOSPASM IN PATIENTS WITH CHRONIC LUNG DISEASE
Do not use Afrezza if you have chronic lung problems such as asthma or COPD. Do not use Afrezza during a low blood sugar reaction (hypoglycemia). If you are allergic to regular human insulin or any of the ingredients in Afrezza, do not use Afrezza as this may cause a significant and severe allergic reaction.
Before using Afrezza, your healthcare provider will take a medical history and do a physical exam and a breathing test (called spirometry) because Afrezza can cause a decline in lung function. Your healthcare provider will also want to test your breathing 6 months after starting Afrezza, and then each year after that.
Tell your doctor if you currently have lung cancer or have had it in the past.
You must test your blood sugar levels while using insulin such as Afrezza. Do not make any changes to your dose or type of insulin without talking to your healthcare provider. Any change of insulin should be made carefully and only under your healthcare provider's care.
The most common side effect of insulin, including Afrezza (insulin human) inhalation powder, is low blood sugar (hypoglycemia), which can be serious and life-threatening. Symptoms of low blood sugar include dizziness or light-headedness, sweating, confusion, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability or mood change, hunger. Before you start using Afrezza, talk to your healthcare provider about low blood sugar and how to manage it.
Tell your doctor about all medicines you take, including prescription and over-the-counter medicines, vitamins or herbal supplements. Taking certain diabetes pills called TZDs (thiazolidinediones) with Afrezza can cause heart failure even if you have never had heart failure or heart problems before. If you already have heart failure or other heart problems, it may get worse while you take TZDs with Afrezza.
Before starting Afrezza, it is important to tell your doctor about all your medical conditions including if you have a history of lung problems, if you are pregnant or plan to become pregnant, or if you are breastfeeding or planning to breastfeed.
In addition to low blood sugar (hypoglycemia), other possible side effects associated with Afrezza® include cough, throat pain or irritation, headache, diarrhea, tiredness, and nausea. Please see full Prescribing Information for Afrezza, including Boxed WARNING and www.afrezza.com.