Fiasp Cannot be Legitimately Labeled as Ultra-Rapid.
Sept 22, 2017 4:24:44 GMT -5
edvarney, sla55, and 2 more like this
Post by mango on Sept 22, 2017 4:24:44 GMT -5
Novo Nordisk has already had to make a Fiasp batch recall on 8/25/2017 via the Swiss Medical Association.
www.swissmedic.ch/marktueberwachung/00135/00166/04087/index.html?lang=en
Also of interest is this medicine recommendation document drafted this month by the Lancaster Medicines Management Group on recommending Fiasp.
The Lancashire Medicines Management Group has been established as part of the collaborative commissioning arrangements between the eight Lancashire Clinical Commissioning Groups (CCGs). Its purpose is to provide a platform for a consensus decision making process relating to the use of medicines across the Lancashire NHS footprint, to ensure equity in access to medicines and optimisation of medicines use.”
Hypoglycaemia
• In total, approximately 98% of the subjects in onset 1 and approximately 94% of the subject in onset 2 experienced any event of hypoglycaemia. Severe or blood glucose confirmed hypoglycaemic episodes were reported in 8% of the subjects with type 1 diabetes (onset 1) during the trial compared to 3.5% in the patients with type 2 diabetes (onset 2).
• The mealtime Fiasp had a statistically significant higher rate of hypoglycaemic episodes (severe or BG confirmed) the first hour after meal compared to NovoRapid in patients with type 1 diabetes.
• Two hours after meal a difference was still present but this was not significant. The group randomised to post-meal Fiasp had rates of hypoglycaemic events similar to the subjects using NovoRapid.
• For patient with type 2 diabetes there was a statistically significant difference with higher rates of corresponding definitions of hypoglycaemic episodes two hours after meal (a difference was also seen the first hour after meals but this was not statistically significant). [6]
Body Weight
• In onset 1 in subjects with type 1 diabetes, mean body weight increased slightly from baseline to week 26 in all 3 treatment groups (0.67 kg for Fiasp (meal), 0.70 kg for Fiasp (post-meal) and 0.55 kg NovoRapid, respectively). There was no statistically significant treatment difference after 26 weeks of treatment. [1]
• In onset 2, in subjects with type 2 diabetes, mean body weight increased from baseline in both treatment groups to a similar extent, with no statistically significant difference between treatments after 26 weeks (2.67kg for Fiasp and 2.68 kg for NovoRapid). [7]
• In onset 3, in subjects with type 2 diabetes, a statistically significantly greater mean body weight increase was observed in the Fiasp + basal treatment group as compared to the basal group after 18 weeks of treatment (1.83 kg for Fiasp and 0.17 kg for basal insulin). The mean weight gain in the Fiasp + basal group was still below 2 kg and of the magnitude expected when adding bolus insulin to an insulin regimen. [8]
Other Adverse Events
• In total 5 deaths were reported after randomisation in the completed clinical trials. However, the risk of deaths seemed not to reflect a difference between Fiasp and NovoRapid nor an apparent association between insulin aspart and mortality risk.
Limitations
• It may be considered that the documented differences in efficacy or safety (i.e. Changes in glycaemic control and/or the timing of hypoglycaemias) between Fiasp and NovoRapid are not of sufficient clinical relevance to consider Fiasp a different medicinal product.
• There are no comparative studies of post-meal NovoRapid versus post-meal Fiasp.
• In the onset 1 and onset 2 trials, the rates of hypoglycaemic events at 1 hour and 2 hours post-meal were greater in the Fiasp patient group than the NovoRapid patient group.
• The improvement in PPG control could possibly be of clinical relevance, but it is uncertain if the effect on PPG is an independent marker of risk considering the limited effect on HbA1c. Further, the effect of improved PPG control decreased over time.
• The Onset 3 study supported the use of basal-bolus insulin in patients inadequately controlled on basal insulin, although the study did not provide any additional evidence to support the use of Fiasp over other bolus insulins.
• There was an apparent increase in the frequency of injection site reactions in the Fiasp group compared to the NovoRapid especially in type 1 diabetic patients.
www.lancsmmg.nhs.uk/download/newdrug%20reviews/Insulin-Aspart-Fiasp-for-web-site.pdf
Unless the insulin actually mimics endogenous insulin secrection, claims saying it "closely mimics endogenous insulin secrection" are misinformation as every single company attempting to do this has developed nothing more than a faster version of a previous version that still does not even come close to mimicking anything enodogenous. Hypo events occurred more often with the use of Fiasp alone or in combination with a basal insulin, the opposite is true for Afrezza. Wouldn't be surprised if Fiasp doesn't even get FDA approval.
Batch recall - fiasp ultra-fast-acting, injection solution
08/25/2017
Preparation: Fiasp ultra-fast-acting, injection solution
Approval Number: 66202
Active ingredient: Insulinum aspartum
Holder of the license: Novo Nordisk Pharma AG
Batch withdrawal: GS63J11
The company Novo Nordisk Pharma AG withdraws the above-mentioned batch of Fiasp ultra-fast-acting, injection solution to the level of retail trade from the market. The inscription on the ampoule contains a faulty indication of the amount of active compound per total volume (300 U / U = 3 ml instead of 1000 U / U = 10 ml).
The recall shall be made by means of company letters to the customers supplied with the preparation.
08/25/2017
Preparation: Fiasp ultra-fast-acting, injection solution
Approval Number: 66202
Active ingredient: Insulinum aspartum
Holder of the license: Novo Nordisk Pharma AG
Batch withdrawal: GS63J11
The company Novo Nordisk Pharma AG withdraws the above-mentioned batch of Fiasp ultra-fast-acting, injection solution to the level of retail trade from the market. The inscription on the ampoule contains a faulty indication of the amount of active compound per total volume (300 U / U = 3 ml instead of 1000 U / U = 10 ml).
The recall shall be made by means of company letters to the customers supplied with the preparation.
www.swissmedic.ch/marktueberwachung/00135/00166/04087/index.html?lang=en
Also of interest is this medicine recommendation document drafted this month by the Lancaster Medicines Management Group on recommending Fiasp.
The Lancashire Medicines Management Group has been established as part of the collaborative commissioning arrangements between the eight Lancashire Clinical Commissioning Groups (CCGs). Its purpose is to provide a platform for a consensus decision making process relating to the use of medicines across the Lancashire NHS footprint, to ensure equity in access to medicines and optimisation of medicines use.”
Hypoglycaemia
• In total, approximately 98% of the subjects in onset 1 and approximately 94% of the subject in onset 2 experienced any event of hypoglycaemia. Severe or blood glucose confirmed hypoglycaemic episodes were reported in 8% of the subjects with type 1 diabetes (onset 1) during the trial compared to 3.5% in the patients with type 2 diabetes (onset 2).
• The mealtime Fiasp had a statistically significant higher rate of hypoglycaemic episodes (severe or BG confirmed) the first hour after meal compared to NovoRapid in patients with type 1 diabetes.
• Two hours after meal a difference was still present but this was not significant. The group randomised to post-meal Fiasp had rates of hypoglycaemic events similar to the subjects using NovoRapid.
• For patient with type 2 diabetes there was a statistically significant difference with higher rates of corresponding definitions of hypoglycaemic episodes two hours after meal (a difference was also seen the first hour after meals but this was not statistically significant). [6]
Body Weight
• In onset 1 in subjects with type 1 diabetes, mean body weight increased slightly from baseline to week 26 in all 3 treatment groups (0.67 kg for Fiasp (meal), 0.70 kg for Fiasp (post-meal) and 0.55 kg NovoRapid, respectively). There was no statistically significant treatment difference after 26 weeks of treatment. [1]
• In onset 2, in subjects with type 2 diabetes, mean body weight increased from baseline in both treatment groups to a similar extent, with no statistically significant difference between treatments after 26 weeks (2.67kg for Fiasp and 2.68 kg for NovoRapid). [7]
• In onset 3, in subjects with type 2 diabetes, a statistically significantly greater mean body weight increase was observed in the Fiasp + basal treatment group as compared to the basal group after 18 weeks of treatment (1.83 kg for Fiasp and 0.17 kg for basal insulin). The mean weight gain in the Fiasp + basal group was still below 2 kg and of the magnitude expected when adding bolus insulin to an insulin regimen. [8]
Other Adverse Events
• In total 5 deaths were reported after randomisation in the completed clinical trials. However, the risk of deaths seemed not to reflect a difference between Fiasp and NovoRapid nor an apparent association between insulin aspart and mortality risk.
Limitations
• It may be considered that the documented differences in efficacy or safety (i.e. Changes in glycaemic control and/or the timing of hypoglycaemias) between Fiasp and NovoRapid are not of sufficient clinical relevance to consider Fiasp a different medicinal product.
• There are no comparative studies of post-meal NovoRapid versus post-meal Fiasp.
• In the onset 1 and onset 2 trials, the rates of hypoglycaemic events at 1 hour and 2 hours post-meal were greater in the Fiasp patient group than the NovoRapid patient group.
• The improvement in PPG control could possibly be of clinical relevance, but it is uncertain if the effect on PPG is an independent marker of risk considering the limited effect on HbA1c. Further, the effect of improved PPG control decreased over time.
• The Onset 3 study supported the use of basal-bolus insulin in patients inadequately controlled on basal insulin, although the study did not provide any additional evidence to support the use of Fiasp over other bolus insulins.
• There was an apparent increase in the frequency of injection site reactions in the Fiasp group compared to the NovoRapid especially in type 1 diabetic patients.
www.lancsmmg.nhs.uk/download/newdrug%20reviews/Insulin-Aspart-Fiasp-for-web-site.pdf
Unless the insulin actually mimics endogenous insulin secrection, claims saying it "closely mimics endogenous insulin secrection" are misinformation as every single company attempting to do this has developed nothing more than a faster version of a previous version that still does not even come close to mimicking anything enodogenous. Hypo events occurred more often with the use of Fiasp alone or in combination with a basal insulin, the opposite is true for Afrezza. Wouldn't be surprised if Fiasp doesn't even get FDA approval.