A group of Brazilian researchers developed the country’s first self-injectable adrenaline pen. The medication, when made available in this type of device, is applied by the patient himself, in cases of a severe and potentially fatal allergic reaction, a medical condition known as anaphylaxis.
According to the Brazilian Association of Allergy and Immunology (Asbai), adrenaline is currently the only medication available on the market capable of treating cases of anaphylaxis. The self-injectable model, however, can only be purchased in Brazil by import, which makes the cost extremely high.
Fiocruz researcher and neurophysiologist Renato Rozental talks about the 1st self-injectable adrenaline pen developed by Brazilian researchers. Photo: Fernando Frazão/Agência Brasil
Doctor Renato Rozental coordinates the team responsible for the national pen. In an interview with Brazil Agencyhe explained that, despite being the first Brazilian prototype, it is not a “radical innovation”. “You can easily find this pen in Europe, North America, Asia, Oceania”.
“The big question is: why did it take so long for this to happen in Brazil?” asked the Fiocruz researcher.
Rozental recalled that, since 2018, with the break of the monopoly, generic options for the pen on the foreign market caused the price of the device to drop substantially. “But it was still exorbitant.”
“For those who have health insurance, which is very expensive abroad, the price reaches US$100. Those who do not have insurance pay up to US$700. In Brazil, people who have the means, through judicialization processes, are able to import, but the price is still sky high. Importing a pen for R$3,000 or R$4,000 is something outside the Brazilian reality.”
“The majority of the Brazilian population, not only via the Unified Health System (SUS) but also through the private network, does not have access. What we did was structure, looking at pens already on the market. The process is very fast. We started talking last year and we already have a working prototype now.”
Anvisa
Rozental highlighted that, a few months ago, the National Health Surveillance Agency (Anvisa) signed a bilateral agreement with the North American agency Food and Drug Administration (FDA). The proposal is to speed up the entry into Brazil of medicines already approved in the United States.
“Anvisa would have direct access to these results, despite them being confidential. This would greatly facilitate the approval of any device in Brazil. It is a process that we will discuss next week, in Salvador, where we will have a representative from Anvisa who specifically deals with this”, he said, referring to the debate scheduled for next Friday (15) at the Brazilian Congress of Allergy and Immunology.
“On our side, we would be able to have this adrenaline pen ready for distribution in the country in 11 months. But it will depend on this discussion next week, on recognition and release by Anvisa. It’s not in our hands.”
Anaphylaxis
THE Brazil Agencythe president of the Brazilian Association of Allergy and Immunology (Asbai), Fábio Chigres, warned of an “exponential increase” in allergies in Brazil – including cases of anaphylaxis.
“30 years ago, in public hospitals specializing in the treatment of allergies, a reference for these cases, we saw eight or ten cases a year of children with allergies to cow’s milk. Today, I see it in a week.”
Fábio Chigres, president of the Brazilian Association of Allergy and Immunology (Asbai). – Fábio Chigres/Disclosure
According to him, food appears, in the country, as the main cause of allergies among children – especially milk and eggs. “It’s not lobster or something you occasionally eat,” he highlighted.
“And this child with food allergies is much more exposed on the street than when they are indoors. As a result, the quality of life for the entire family becomes very poor. They live waiting for a serious reaction. We have cases of children walking through the dairy section of the market and reacting.”
Among adults, the main cause of allergies, according to Chigres, are medications – especially analgesics and anti-inflammatories, medications that do not even require a doctor’s order at the time of purchase. Antibiotics also account for a considerable number of allergy cases in the adult population, in addition to foods such as crustaceans and shellfish.
“In the specific case of anaphylaxis, it is a very serious allergic reaction that develops quickly,” he said. “This reaction causes anaphylactic shock, an abrupt and very large drop in pressure, which prevents blood from circulating through the body and reaching the brain. The body releases a substance called histamine, which causes a generalized reaction and can affect the skin and lungs, in addition to causing bronchospasm and glottis edema, closing the upper airways.”
“Adrenaline reverses all these symptoms. If I start to have a reaction like this and apply adrenaline, within one to five minutes, I almost completely reverse the anaphylaxis – or allow that person to go to the hospital to complete the treatment”, highlighted Chigres.
“It’s not just about access to adrenaline. I need a device that makes it easy to use. And the Brazilian pen can be applied, on the side of the thigh, by a person who has no training in health.”
According to Chigres, the estimate is that the self-injectable adrenaline pen developed by Brazilian researchers will reach the national market costing around R$400.
