International Symposium on Technology in Diabetes (Sitec)

[harryx1]

The Brazilian Society of Diabetes (SBD) held the International Symposium on Technology in Diabetes (Sitec) in São Paulo

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"Among the novelties presented highlight the Afrezza insulin"


Diabetes Technology
May 28, 2015
0

Luiz Antônio de Araujo, Endocrinologist, director of the Brazilian Society of Diabetes

The technology has evolved in recent years, it is very important for diagnosis as well as for the control of diabetic patients. New insulins, infusion pumps, sensors, applications, websites, glucose monitors, blood glucose management and other so many products are coming to market and have become tools that effectively contribute in the treatment of this disease, which afflicts about 12 million Brazilians.

The Brazilian Society of Diabetes (SBD) held the International Symposium on Technology in Diabetes (Sitec) in São Paulo, with the participation of renowned speakers. Among the novelties presented highlight the Afrezza insulin, quickly and nasal application action, replacing subcutaneous injectable applications; a new calculator - Accu-check Performa Conect - which stores the results of glucose in the cloud and calculates the need for insulin for carbohydrate counting; glucose Holter - iPro2, which performs continuous glucose monitoring, by a sensor placed in the subcutaneous tissue; new pumps suspending the insulin infusion automatically hypoglycaemia (decrease in blood glucose); artificial pancreas, a system that uses a subcutaneous glucose sensor that monitors blood glucose levels, along with insulin infusion pump. Both are connected by computer programs that informs and calculates the quantity of insulin to be released to maintain blood glucose levels within normal parameters. In this way, the patient would be free of the need to do blood glucose tests (fingertip) and multiple daily insulin injections, with the potential to improve their quality of life.

What will have the biggest impact in the routine of patients is the new blood glucose meter, the FreeStyle Libre, which finishes with the fingerstick tests, as uncomfortable for those diabetic patients who need to do it, sometimes five or ten times daily. Through a small filament 4mm inserted under the skin of the forearm, painlessly connected to a transmitter reads the glucose levels. Just approach the reader, the value of blood glucose appears in the display, as often as needed.

[kc]

I am wondering if Brazil is a fast path nation with utilizing the FDA requirements. I had read somewhere that it was but can't find that information again. 

portal.anvisa.gov.br/wps/wcm/connect/7f624f8046fea039ba0abb41cdd33a01/RDC+57-2009+%28English%29.pdf?MOD=AJPERES

Info on the

portal.anvisa.gov.br/wps/portal/anvisa-ingles/anvisaingles/Home/!ut/p/c5/04_SB8K8xLLM9MSSzPy8xBz9CP0os3hfRw8jD0NnA3cLSw83A08jS18nMwNnAxMDA6B8pFm8AQ7gaDCqmwa6w0GxhKwixN8FqMIx1NnM3M_QwtgcIo_HfD-P_NxU_Uj9KHOc9vgb6UfmpKYnJlfqF-SGgkCEQZZJKABDMtSn/dl3/d3/L0lJSklna21BL0lKakFBTXlBQkVSQ0pBISEvNEZHZ3NvMFZ2emE5SUFnIS83X01BSDJIMUMwRzg5SEYwSTI5TUI2MEMwNE8yL04yaWQ4MTg5MDAxMQ!!/?WCM_PORTLET=PC_7_MAH2H1C0G89HF0I29MB60C04O2020591_WCM&WCM_GLOBAL_CONTEXT=/wps/wcm/connect/Anvisa+Ingles/Anvisa/Health+Protection/Active+Pharmaceutical+Ingredients/

MOU between FDA and Brazil

www.fda.gov/InternationalPrograms/Agreements/MemorandaofUnderstanding/ucm330164.htm

Another article from Brazil.

translate.google.com/translate?hl=en&sl=pt&u=http://www.draanafigueiredo.com.br/insulina-inalatoria&prev=search

The time for action is initiated 15 minutes after inhalation of dust and has peak action after 50 minutes. Its action completely ends after about 2.5 hours. So it should be used to reduce post-prandial blood glucose. It is wise to inhale it just before meals.

Afrezza has just been approved in the US and Brazil has not been tested, so the long-term safety is uncertain in daily clinical practice. In clinical studies have shown to be safe and well tolerated. The most common side effects reported by users were cough, throat irritation and headache.

For security reasons its use is indicated only for over 18 years. Studies in children are being conducted and we expect its release for children in the coming years. It is also contraindicated in patients chronic lung diseases such as emphysema, asthma and bronchitis in addition it can not be used by smokers.

Before its release, AFREZZA users had a slight decrease in lung function. Therefore, spirometry tests should be performed before the use, after 6 months and yearly repeated for motorizing any adverse lung effects. It is not known whether this drug is able to cause lung cancer and safety studies are ongoing.

We look forward to the arrival of the drug in Brazil and release to its use in children. Although it is not a cure for diabetes since proper nutrition, exercise and glicosimetria should be kept at least we will have more comfort in the administration of insulin and certainly less refused treatment.

[mnholdem]

Brazil to Expedite Review and Approval Process, Recognize Foreign Audits and Inspections

Excerpt:

One new measure is the creation of the Electronic Registration System of Medicines, which will start on 15 April 2013, and will apply to new drug applications and should reduce by 40% the analysis time of each request. The goal is to ensure that 100% of the registration processes for new drug evaluation will be done by electronic means by the end of 2013.

Another goal is to reduce the time it takes the agency to review and approve applications from nine months on average to six months for technological innovation and priority medications for hypertension, diabetes and cancer. The reduction to six months would be consistent with the review time of other agencies such as the US Food and Drug Administration (FDA).


See more at: www.raps.org/focus-online/news/news-article-view/article/3072/brazil-to-expedite-review-and-approval-process-recognize-foreign-audits-and-ins.aspx#sthash.I3YeRZdD.dpuf

I imagine there are more recent updates available for the Brazilian new drug approval process. Something might will be mentioned about this at the symposium that harry posted...