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News Breaks
June 27, 2014
15:29 EDTMNKDFDA approves Afrezza to treat diabetes
The U.S. Food and Drug Administration today approved Afrezza Inhalation Powder, a rapid-acting inhaled insulin to improve glycemic control in adults with diabetes mellitus. Afrezza is a rapid-acting inhaled insulin that is administered at the beginning of each meal, or within 20 minutes after starting a meal. Afrezza has a Boxed Warning advising that acute bronchospasm has been observed in patients with asthma and chronic obstructive pulmonary disease. Afrezza should not be used in patients with chronic lung disease, such as asthma or COPD because of this risk. The most common adverse reactions associated with Afrezza in clinical trials were hypoglycemia, cough, and throat pain or irritation. The FDA approved Afrezza with a Risk Evaluation and Mitigation Strategy, which consists of a communication plan to inform health care professionals about the serious risk of acute bronchospasm associated with Afrezza. The FDA is requiring the following post-marketing studies for Afrezza: a clinical trial to evaluate pharmacokinetics, safety and efficacy in pediatric patients; a clinical trial to evaluate the potential risk of pulmonary malignancy with Afrezza, which will also assess cardiovascular risk and the long-term effect of Afrezza on pulmonary function; two pharmacokinetic-pharmacodynamic euglycemic glucose-clamp clinical trials, one to characterize dose-response and one to characterize within-subject variability. Afrezza is manufactured by MannKind.
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June 30, 2015
11:47 EDTMNKDMannKind's Afrezza lags behind in inhaled insulin market, The Street reports
The number of prescriptions written for MannKind's (MNKD) Afrezza is lagging behind in the diabetes market, reports The Street. This comes five months after Sanofi (SNY) launched the product. Afrezza is also under-performing Exubera, the first inhaled insulin launched by Pfizer (PFE) nine years ago. Reference Link

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