HGP – Kaléo Announces 2017 U.S. Return Of Auvi-Q® (Epinephrine Injection, Usp) Auto-Injector For Life-Threatening Allergic Reactions
RICHMOND, VA. (October 26, 2016) – Kaléo, a privately-held pharmaceutical company, today announced that it will reintroduce AUVI-Q® (epinephrine injection, USP) auto-injector to the U.S. market in the first half of 2017. AUVI-Q is a prescription medicine used to treat life-threatening allergic reactions, including anaphylaxis, in people who are at risk for or have a history of serious allergic reactions.
“Today’s 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.
“For the millions affected by life-threatening food allergies, an epinephrine auto-injector serves as a lifeline,” said James R. Baker, Jr., MD, CEO and Chief Medical Officer at Food Allergy Research and Education (FARE). “These lifesaving devices must be accessible and affordable, and Americans should have options when it comes to selecting the right auto-injector for their family.”
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.”
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