Kaléo, a privately held pharma company, 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...”
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.
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.