Anvisa Approves First Inhaled Insulin in Brazil

By Xiu Ying, Contributing Reporter

RIO DE JANEIRO, BRAZIL – The National Health Surveillance Agency (Anvisa) authorized the marketing of the first inhalable insulin in the country. The decision granting registration of the product was approved last Thursday, May 30th, and published this Monday, June 3rd, in the Diário Oficial da União (Federal Gazette).

Named Afrezza, the new insulin is sold in powder form, in capsules with three different types of dosage. The diabetic patient needs to insert the capsule into the inhaler and draw in the powder for use.

The substance reaches the lungs and is absorbed into the bloodstream, where it is used to reduce blood sugar levels. So far, only injectable insulin has been available in the Brazilian market.

According to experts, although it represents an alternative for treating diabetes and a benefit in quality of life by reducing the number of injections, Afrezza has limitations. It is unable to replace all daily insulin applications, it has a limited range of dosage and is unsuitable for patients with lung conditions and those under eighteen years of age.

On the other hand, it is easier to carry and store as it does not require refrigeration and may reduce the number of needle pricks that the patient has to undergo daily.

Inhaled insulin may only replace fast-acting or ultra-fast insulin applications, also called “bolus”. This type of insulin is typically used before each meal when the body needs a larger amount to compensate for sugar intake.

The other type of insulin, “basal”, of slower action, is generally used only once daily and cannot be replaced by the inhaled drug, as explained by Lívia Porto, an endocrinologist at the Centro Especializado em Obesidade e Diabetes of Hospital Alemão Oswaldo Cruz, which specializes in treating obesity and diabetes.

“If a diabetic patient is treated using this basal-bolus therapy, he or she typically takes at least four injections a day: one basal and three boluses, for breakfast, lunch, and dinner. Switching to an inhaler would reduce it from four daily doses to one. It would be a gain in quality of life, although it would not entirely replace the injection”, says the doctor.

For Heraldo Marchezini, CEO of Biomm, the company responsible for product distribution in Brazil, Afrezza’s ease of handling and use represents an improvement in the quality of life of patients. “At mealtimes, the patient often needs to use insulin in a social environment outside the home. The inhalable solution can be faster and more discreet. The inhaler fits in the palm of your hand. It’s a great innovation in terms of use,” he says.

He asserts that the product is suitable for type 1 and 2 diabetes patients. Nevertheless, considering that most type 2 diabetics are treated with pills and not with insulin, the main beneficiaries of the new product would be type 1 diabetic patients, who must obligatorily be treated with insulin.

“In the case of type 2 diabetics, Afrezza would be recommended only for patients who are unable to control blood glucose by only using oral medication,” explains endocrinologist Freddy Eliaschewitz, scientific advisor to the Brazilian Society of Diabetes and director of the Clinical Research Center CPclin, a Brazilian institution that participated in studies on inhaled insulin. According to the specialist, of the approximately 15 million Brazilians suffering from diabetes, it is estimated that 10 percent suffer from type 1 diabetes and 90 percent from type 2.

Afrezza producer MannKind Corporation from Westlake Village, California, and BIOMM SA from Belo Horizonte had announced in May 2017 that they entered into a supply and distribution agreement for the commercialization of Afrezza Inhalation Powder in Brazil.