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AUVI-Q to return in early 2017
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The pharmaceutical company kaléo announced the epinephrine auto-injector AUVI-Q will be available again for the treatment of life-threatening allergic reactions in the first quarter of 2017, and hopes to make it affordable to all patients.
“According to a recent study by the Asthma and Allergy Foundation of America, nearly one in 50 Americans are at risk of anaphylaxis, although the precise incidence is unknown and likely underreported,” Mark Herzog, vice president of corporate affairs for kaléo, told Healio Family Medicine. “We believe all those with life-threatening allergies should have options when it comes to choosing an epinephrine auto-injector.”
“[This] represents an important milestone for the life-threatening allergy community, which has suffered from a lack of epinephrine auto-injector options for far too long,” Eric Evans, vice president of product development and industrialization at kaléo, said in a press release.
The auto-injector is produced on a fully automatic robotic assembly line, with more than 100 mechanical quality checks performed on each device. The new version is about the size of a credit card and has many features previously unseen in epinephrine auto-injector devices, according to the release.
“[AUVI-Q includes] a voice prompt system that guides a user with step-by-step instructions through the delivery process, and a needle that automatically retracts following administration,” Herzog said.
Kaléo officials said they are committed to making their device financially accessible to all.
“We believe that patients should have options when it comes to epinephrine auto-injectors for life-threatening allergic reactions,” Spencer Williamson, president and CEO of kaléo said in a press release. “… the patient should be able to obtain the product without insurance barriers or being subjected to a high out-of-pocket cost. As we prepare to make AUVI-Q available once again in the United States, our priority is to return AUVI-Q to the market as an epinephrine auto-injector alternative that all patients can afford.”
AUVI-Q’s previous manufacturer, Sanofi, voluntarily recalled its version of AUVI-Q in 2015 citing a possible “inaccurate dosage delivery,” Herzog said, adding Kaléo was not a part of this recall. – by Janel Miller
Disclosures: Herzog, Evans and Williamson are all employed by kaléo.
Perspective
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Tonya Winders
The reintroduction of AUVI-Q by kaléo is exciting news for patients and families at risk for anaphylaxis, a life-threatening allergic reaction. We are optimistic kaléo has made the necessary improvements to the product to ensure accurate, reliable and consistent dosing and we’re hopeful AUVI-Q will reenter the market at a price point both accessible and affordable.
We encourage patients and families to discuss epinephrine auto-injectors with their primary care doctor or board-certified allergist to determine which option is best for them.
Along with questions about availability, cost, use and maintenance of epinephrine auto-injectors, patients should ask about anaphylaxis symptoms to watch for and when it’s necessary to use an epinephrine auto-injector. Epinephrine remains the only medication that can halt the progression of anaphylaxis and should be given as soon as symptoms occur.
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