Decision on Inhalable Insulin Set for Summer
New version would treat types 1 and 2
On April 7th, the FDA decided to delay their decision on Afrezza, an ultra fast-acting inhalable insulin developed by MannKind Corporation, until July 15 – a week after an advisory panel of physicians and experts voted overwhelming in favor of approval. On April 1, the panel voted 13 to 1 to recommend approval of Afrezza for use with type 1 diabetes and 14 to 0 for use with type 2 diabetes. While the FDA is not required to follow theses recommendations, they generally are a good indicator of how the FDA will rule.
The FDA has approved similar products in the past. In 2006, Pfizer brought an inhaled insulin known as Exubera to the market. The product had a significantly larger inhaler and was not broadly received. After two years, Pfizer pulled the drug from the market resulting in a multi-billion dollar loss. MannKind believes Afrezza will be different in part because of its smaller, more discreet inhaler. The Exubera device was large, some joked it resembled a bong. The Afrezza device is more the size of other common inhalers.
Afrezza's is an ultra fast-acting insulin. That speed allows patients to take it with or immediately after a meal, allowing them better balance insulin with what they've eaten. This is different from injected insulin, which patients are often prescribed to take before a meal, in anticipation of what may be eaten. This can lead to misestimating and hypoglycemic episodes.
However, while the data presented shows inhaled insulin managing A1C better than a placebo, injected insulins appear to result in an even greater A1C reduction.
The safety of inhalable insulin was also an issue of discussion by the advisory panel. Data showed that there were more cases of lung cancer in the group talking Afrezza than in the control group. While the difference was small and not definitive, it was still cause for concern. Patients with existing lung issues, including COPD, may not do well with Afrezza. Cough was an issue for some. The panel recommended FDA consider labeling of pulmonary conditions and long-term studies post market.
The committee voted to approve Afrezza as an option for patients to consider with their health care professionals. In explaining her vote, Rebecca Killion, the consumer representative on the panel said fthat or many, "Injections are exhausting. They are frustrating. They are disruptive and at this point inescapable." Afrezza, she hopes, will allow patients an alternative.
Bennet Dunlap spoke as a patient advocate at the Afrezza hearing. He cited a recent JAMA paper1 on the number of insulin-induced emergency room visits due to hypoglycemia. The leading causes of those ER visits, cited by JAMA, were eating less food than anticipated by the insulin dose and confusing insulin.
NOTE: The information is not intended to be a replacement or substitute for consultation with a qualified medical professional or for professional medical advice related to diabetes or another medical condition. Please contact your physician or medical professional with any questions and concerns about your medical condition.
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