FDA Endocrinologic and Metabolic Drugs Advisory Committee
On November 8, 2012, the FDA Endocrinologic and Metabolic Drugs Advisory Committee will discuss the safety and efficacy of new drug applications (NDAs) 203313, insulin degludec/insulin aspart [rDNA origin] injection and 203314, insulin degludec [rDNA origin] injection, manufactured by Novo Nordisk Inc. The proposed indication (use) for these applications is for the treatment of Type 1 and Type 2 diabetes mellitus.
There was an invitation for public comment. I applied, was accepted to comment and will be offering the following: I added a little and have tried to include it here in red as best as I can remember it and my notes. I am 100% confident I goofed some of tit up but I think I got out the gist of it.
My name is Bennet Dunlap. Following three doctors is a little intimidating. I am not a physician, I am a parent of two teens with Type 1 Diabetes, I am a frequent and maybe even respected diabetes social media writer, and am a member of Diabetes Advocates an association of e-patients who helped with gas money to be here. I have no relationship with the drug sponsor.
Social media is often critical of the pace of advancements coming to market and the FDA. In that context I would like to thank the FDA and this committee and each of the individuals serving here for efficiently considering new insulin alternatives for people with diabetes. Diabetes care varies from individual to individual. Most people with diabetes who use insulin to managed their blood sugar need basal insulin. While many people are successful with the insulin products on the market, others are not as fortunate and so may benefit from wider alternatives.
I regularly tell people online that your diabetes may vary. Just as different people respond to fast acting insulin analogs in unique ways, it is likely that patients, with their physicians, will discover that different basal insulins suit patients’ particular needs in individual ways. I applaud a systematic review of additional insulin options.
I hope that the committee maintains and sharpens an ongoing institutional expertise in evaluating new insulin products. Today’s basal insulin candidates are likely to be followed by even more innovative products, specifically the glucose responsive insulins that are in development. These have the potential to revolutionize diabetes self management. I trust that the experience gained in evaluating basal now insulins can serve to inform consideration of these other insulins when they get to the review process. I hope that you look beyond A1C as a measure of control to include glucose variability in your consideration of insulins.
I appreciate the comments of the representative of the Endocrine Society on hypoglycemia. This morning's conversation on hypos at one point suggested that since night time data is hard to get that daytime results could be an indication of night time. As a parent of type 1 kids I feel a need to state the obvious, nigt and day are as different as... well.. night and day. Parents fear night time hypos because that is what has killed a number of kids this year. I realize this is not a pediatric application. Type 1 diabetes often presents in young children. My kids were 7 and 9 at diagnosis. I have many friends who’s children were much younger. Because of children’s size, activity patterns, growth patterns, variable appetites and communication skills parents often struggle to manage diabetes in children. The expeditious and judicious review of innovative products for pediatric use will be greatly appreciated by all parents of children with diabetes and our care teams.
Thank you for safe and effective tools to help people live with diabetes.