BREAKING NEWS: Auvi-Q Auto-Injector Returns to Treat Life-Threatening Allergic Reactions
A few weeks ago, I was contacted by the founder of AUVI-Q. Established by twin brothers who had life threatening food allergies, the two brothers leveraged their personal experience and one brother’s work as a paramedic to invent and design a device for 21st century families dealing with life-threatening allergies. With innovative design, a smarter operating systems and voice technology AUVI-Q talks and walks someone through the use of the device during a life threatening reaction. The voice technology feature is similar to Siri, guiding a patient through use during a life-threatening reaction.
If EpiPen was invented in 1977 for the military, AUVI-Q was innovative in its design: invented in the 21st century by and for people with life-threatening food allergies.
The product design is smart and leverages 21st century technology. It is part of the new frontier in healthcare and represents a health+tech company that meets the changing health needs of our families.
I spoke with the founder of AUVI-Q as the #epigate crisis hit, as the founders had been through so much as a competitor in this space.
With the announcement of the new release of AUVI-Q, kaléo, the inventor of AUVI-Q, commits to making the innovative epinephrine auto-injector with industry-first features available in the first half of 2017 as an alternative for the life-threatening allergy community. Since bringing the company back under the inventors roof, the company will provide new manufacturing and quality system controls to ensure reliable and accurate epinephrine dose delivery.
The release of the device represents a milestones for its founders who originally developed the product because they wanted an easy to carry, smarter technology themselves. Today they now have children who need their Auvi-Q device, too.
On the heels of #epigate, it can’t come soon enough.
Last night, I spoke with one of the brothers and founders, Eric Edwards, and the company’s CEO and President, Spencer Williamson. They shared the following:
“This news 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,” said Evan Edwards, Vice President of Product Development & Industrialization at kaléo. “As the inventors of AUVI-Q, my brother and I have dedicated our lives to researching and developing an innovative epinephrine auto-injector that would do for severe allergy sufferers what the AEDs did for cardiac arrest in the community; namely a product that could assist and guide even an untrained user through a life-threatening emergency.”
AUVI-Q is a compact epinephrine auto-injector with industry-first features, including 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. AUVI-Q is engineered to help patients and their caregivers to confidently administer epinephrine in life-threatening allergic emergencies.
After regaining the rights to AUVI-Q, kaléo conducted a thorough manufacturing assessment and invested in new technology and quality systems to ensure accurate, reliable and consistent delivery from the product. AUVI-Q is manufactured on an intelligent, high-tech, 100% automated robotic production line with more than 100 automated quality checks on each AUVI-Q, ensuring a streamlined and consistent production process.
Eric Edwards M.D., Ph.D, Vice President, Product Strategy at kaléo, added, “As a patient and parent of children with life-threatening allergies, I know how the moment of an allergic emergency can unfold- with panic and fear- and that is why I believe and trust in AUVI-Q, not only for myself, but also for my children and other families who might have to depend on it. Driven by this reality, kaléo strives for flawless manufacturing to ensure each AUVI-Q is built to exceptional quality standards.”
Kaléo is aware of the epinephrine auto-injector access and affordability challenges confronting patients and is working to engage with various stakeholders, including wholesalers, insurance companies, pharmacies and pharmacy benefit managers, to ensure that all patients regardless of insurance coverage, have affordable access to AUVI-Q.
“We believe that patients should have options when it comes to epinephrine auto-injectors for life-threatening allergic reactions,” said Spencer Williamson, President and CEO of kaléo. “When a health care practitioner prescribes AUVI-Q, determining that it is best for a patient, we believe that 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.”
“We are very excited about patients once again having a choice in epinephrine auto-injectors,” said Eleanor Garrow-Holding, President and CEO of the Food Allergy & Anaphylaxis Connection Team (FAACT). “As food allergy advocates and families personally affected by food allergies, we understand that each person with food allergies has individual needs and comfort levels. Those living with life-threatening allergies deserve innovative products and choices that meet their individual needs. As such, we are grateful that patients will have options when selecting their potentially life-saving epinephrine auto-injector.”
The latest updates regarding the return of AUVI-Q will be available to members of the public who register online at www.auvi-q.com.
About Anaphylaxis
Anaphylaxis (pronounced ana-fuh-lak-sis) is a serious allergic reaction that happens quickly and may cause death. Anaphylaxis can occur as a result of exposure to allergens including tree nuts, peanuts, milk, eggs, fish, shellfish, soy, wheat, insect bites, latex and medication, among other allergens.
About AUVI-Q
AUVI-Q® (epinephrine injection, USP) Auto-injector is a prescription medicine used to treat life-threatening allergic reactions, including anaphylaxis, in people who are at risk for or who have a history of serious allergic reactions. AUVI-Q contains epinephrine, a well-established, first-line treatment for severe, life-threatening allergic reactions that occur as a result of exposure to allergens including food such as peanuts, tree nuts, fish, shellfish, dairy, eggs, soy and wheat; insect stings or bites; latex and medication, among other allergens and causes.
Invented by twin brothers Eric and Evan Edwards, a physician and engineer who each suffer from life-threatening allergies, AUVI-Q is a compact epinephrine auto-injector with industry-first features, including a voice prompt system that guides a user with step-by-step instructions through the epinephrine delivery process, and a needle that automatically retracts following administration. In emergencies such as anaphylaxis, it is often individuals without medical training who need to step in and deliver potentially life-saving rescue therapy. AUVI-Q was designed – through careful analysis of the situations where epinephrine is used and with significant input from the allergy community that relies on it – to reflect Human Factors Engineering (HFE). HFE is about designing products or systems that are easy to operate and, most importantly, support correct use, with the goal to remove the potential for error.
Please see the full Prescribing Information and the Patient Information at www.auvi-q.com.
You can learn more about Kaléo, a privately-held company headquartered in Richmond, Virginia here www.kaleopharma.com.
You are encouraged to report negative side effects of for any prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
